"Initiating the study design and protocol process in a structured manner while incorporating CDISC standards use drives efficiency throughout the entire study life,” said David Gemzik, Chair of the Protocol Representation Group. “The Toolkit creates a foundation upon which a standards-driven approach can be implemented."

The next release of the Toolkit, coming later in 2012, will include the PRM Protocol Wizard. The Wizard will allow the end user to simply “plug and play” different protocol elements into a simple-to-use web-based form. What once took hours to reengineer into different formats will require only a few ‘button clicks.’ The underlying technology for the PRM Protocol Wizard is being contributed by Medidata Solutions, a longtime CDISC Member Organization and Registered Solutions Provider. “Support for industry standards is a crucial part of Medidata’s vision for optimizing clinical research,” said Michelle Marlborough, Director of Product Management at Medidata.

“We are very excited that with the PRM Protocol Wizard, the final frontier for clinical research standards has been breached.” “We are extremely pleased that Medidata has offered this Toolkit openly to CDISC members to streamline their research, from protocol development throughout the study process to reporting,” said Rebecca Kush, President and CEO of CDISC. “This is what has been missing from the PRM since Version 1.0 was released in 2010; it provides a means for protocol authors to use the model without having to be technology experts.”

The CDISC Protocol Representation Toolkit has been released on the CDISC website. To access the toolkit, please visit the Members Only area.

ABOUT CDISC

CDISC is a 501(c)(3) global non-profit charitable organization, with nearly 300 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations can decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.

PK Tandon, Clinical Science Officer, Clinical Development, and an Executive Sponsor of both the GetSMART and RegistryNXT! Programs at Genzyme stated “We are very pleased to have received these awards and even more pleased to see the beginnings of adoption in parts of the broader Sanofi organization. This was truly a team effort with input from various stakeholders. We live in an increasingly complex clinical data environment. CDISC standards have helped to streamline our information handling processes, facilitated exchange with external parties, and improved our ability to create integrated datasets to speed answers to regulatory and scientific questions.”

“We are delighted to congratulate the Genzyme teams for their extraordinary work in earning these awards,” stated Rebecca Kush, President and CEO, CDISC. “Both GetSMART and RegistryNXT! are stellar examples of how to gain the most value from CDISC standards---building them into the process from the start and beginning with the end in mind. It is very gratifying to see how CDISC standards can be applied so effectively to provide real business value within the clinical research industry as well as value for patients.”

GetSMART achieves efficiency by combining global business process and technology with standards by consistently defining information to facilitate data reuse and exchange with internal and external partners, to streamline business processes, and to meet current and likely future regulatory guidelines and mandates. GetSMART was successfully implemented at Genzyme and is viewed as a model for parts of the Sanofi R&D organization. Genzyme was able to simplify business processes and increase return on investment through the use of several CDISC standard solutions:

• CDISC CDASH and the CDISC Lab Model for streamlining data collection and database development, enabling data processing efficiencies and improving communication, data exchange and coordination of activities between Genzyme and partners such as CROs, Central Labs, and EDC vendors;

• Incorporating CDISC data submission standards (SDTM) into CDASH case report forms (CRFs) minimizes and automates the transformations required to produce submission data sets and allows reuse of CDISC standard analysis dataset model (ADaM) datasets;

• Development of a Metadata Repository (MDR), as part of Sanofi’s MAESTRO program, will provide an essential foundation for achieving the vision of a metadata-driven clinical data lifecycle by facilitating the definition, use, maintenance and governance of Genzyme’s clinical information standards.

RegistryNXT! is a state-of-the-art, standards-based, data collection and near real-time reporting platform for a Global Patient Registry. The platform, which has won the award for value to patients, enables observational studies to collect uniform data, and analyze specified outcomes, for patients with a particular disease or condition. RegistryNXT! improves and optimizes the quality of care for patients worldwide through the publication of registry data and evidence-based disease management recommendations; supports the evaluation of long-term treatment effectiveness; supports post marketing commitments regarding long term patient safety, as well as reimbursement, market access and product label expansions. RegistryNXT! is based upon the Biomedical Research Integrated Domain Group (BRIDG) model, which is a collaborative domain analysis model developed and governed by CDISC, HL7, NCI and FDA, with a scope of protocol-driven research and patient safety. The platform has already implemented a registry for Gaucher Disease, and is being adopted on new registries for Fabry and Pompe diseases---all on the same standards base.

Sue Dubman, head of Genzyme’s Standards and Architecture Team at the time and now in Sanofi’s R&D IS organization, stated that “the key secrets to success in both GetSMART and RegistryNXT! were active involvement by the business and treating and understanding that both programs involved significant organizational and business process change. We implemented standards in new ways to get new results”.

ABOUT CDISC

CDISC is a 501(c)(3) global non-profit charitable organization, with nearly 300 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations can decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.

The meeting will endeavor to advance work initiated at previous annual FDA Computational Science meetings by bringing together the FDA, industry and academia to provide updates on ongoing current initiatives within the FDA and to establish collaborative working groups to address current challenges related to the access and review of data to support product development. These collaborative working groups will pursue possible solutions and practical implementations with the goal of helping the broader community align and share experiences to advance computational science, while exploring the advantages of using CDISC standards more extensively throughout the research process.

“Since supporting data standards is an essential part of the PhUSE Mission Statement, one of our vital activities is to collaborate with organizations like CDISC to ensure an efficient adoption of standards within the industry,” commented Benjamin Szilagyi, PhUSE Director of Industry Links. “This symposium is a great opportunity to discuss practical applications of these standards among day to day users and feed the results back to CDISC for further consideration. We therefore see the CDISC-PhUSE partnership as an important strategic alliance to drive efficiency and quality in our industry and bring innovative drugs faster to the market.”

"Since CDISC is primarily focused on standards development and training, we don't always have adequate visibility in the implementation and application of our standards on actual research studies”, added Wayne Kubick, Chief Technical Officer of CDISC. “So, we are very pleased to have this opportunity to work more closely with the PhUSE community, who can provide greater insight into the best practice use of standards, and foster creation of better tools to encourage more widespread global adoption of CDISC standards.”

Registration for this meeting has sold out at this point. Any who cannot attend should watch the CDISC and PhUSE websites for progress reports. The goal is to have the working groups, each with an overarching theme of standards, continue beyond the actual meeting to provide a collaborative testing environment to ensure the day to day implementation issues are being discussed and addressed and to share best practices broadly. Streamlining the access and review of data to support product development should ultimately benefit of patients worldwide.

ABOUT CDISC

CDISC is a 501(c)(3) global non-profit charitable organization, with nearly 300 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations can significantly decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.

ABOUT PhUSE

PhUSE is an independent, not-for-profit organization run by volunteers with over 1600 members worldwide. PhUSE provides the industry with the premier platform for creating and sharing ideas, tools, and standards around data, statistical and reporting technologies; PhUSE is supported by a community of professionals who are passionate about the advancement of clinical information. Since its inception PhUSE has expanded from its roots as a conference for European statistical programmers to a global platform for the discussion of topics encompassing the work of Data Managers, Biostatisticians, Programmers, and eClinical professionals. The PhUSE mission is to Share – Contribute – Advance clinical information.

The goal of the CDISC Device Team, comprised of representatives from AdvaMed member device companies, CDISC experts, FDA-CDRH (Center for Devices and Radiological Health), and FDA-CBER (Center for Biologics Evaluation and Research), has been to identify the basic data collection fields, the submission variables, and associated metadata and mappings to support the majority of device studies and modalities, i.e. diagnostic devices, implantable devices and imaging devices. “These seven new proposed SDTM Device domains are a major milestone for the CDISC Devices Team,” quoted Carey Smoak of Roche, charter member and current Co-Leader of the CDISC Devices Team. “We encourage review from the clinical research community in the effort to ensure that this draft standard effectively meets the needs of all audiences.”

We anticipate that in the coming years there will be a series of continuing enhancements and additions to this initial device standard document. Developments of this kind are not possible without the dedicated efforts of numerous CDISC volunteers and members representing organizations across the healthcare and biopharmaceutical industries. Additional device companies interested in participating in the development of device standards are encouraged to consider collaborating with CDISC to lend their voices to the continual process of standards improvement. “Without the support of our members, volunteers and sponsoring companies, progress on this evolving and important device standard would not have been possible,” added Rhonda Facile, CDISC Senior Director of Standards and Development.

In recognition of the development of the draft Device Standard, all new device companies that join CDISC before the end of April will receive a 10% discount off the cost of their membership. For information on CDISC membership, please visit the CDISC website: http//www.cdisc.org and click on “Membership,” or contact Sheila Leaman, CDISC Global Relations Manager: sleaman@cdisc.org.

ABOUT CDISC

CDISC is a 501(c)(3) global non-profit charitable organization, with nearly 300 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations can decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.

With CDISC’s expanded efforts in Europe, there is great excitement and anticipation surrounding the upcoming 2012 CDISC European Interchange, set for 16-20 April in Stockholm, Sweden. The Plenary session will begin with opening remarks by the CDISC Board Chair, Paula Brown Stafford and Chair-elect Pierre-Yves Lastic, who has also led the E3C for the past two years. Plenary speakers will be an expert line-up: Professor Marie Lindquist of the Uppsala Monitoring center, who is working with CDISC and the World Health Organization (WHO) on an important project; Dr. Bernard de Bono of the European Bioinformatics Institute, who will speak about some of the IMI initiatives in which CDISC is involved; Ms. Lisa Spellman, Secretariat of the International Standards Organisation’s (ISO) Technical Committee on healthcare standards (TC215); representatives from the U.S. Food and Drug Administration (FDA); CDISC President, Dr. Rebecca Kush and new CDISC Chief Technology Officer, Wayne Kubick. The EU Interchange week will also include the Annual Meeting of the CDISC Board of Directors and a CDISC Advisory Board (CAB) meeting. “We are extremely pleased to have such a qualified, diverse and relevant set of Plenary session speakers, and the presentations to follow have been carefully selected from excellent abstracts on real-world implementation experiences with CDISC standards globally,” commented Dr. Lastic of Sanofi. “We hope to attract those who have attended before in addition to a new set of attendees in new areas where CDISC standards are now developing significance, such as devices, biotechnology and therapeutic areas. With the CDISC entity in Europe, the opportunities for CDISC continue to expand exponentially here.”

The CDISC Europe Foundation was established as a non-profit entity in Brussels, Belgium in July 2011. This newly established entity will assist CDISC in meeting the needs of its Europe-based members, including IMI, by offering localized support and participation in projects and events located throughout the continent. “I’m really excited about CDISC’s growing footprint in Europe that has come about through the CDISC Europe Foundation,” said Bron Kisler, VP Strategic Initiatives at CDISC. “In a short period of time it has enabled CDISC to become a partner organization on several key IMI projects (such as BioVacSafe, EHR4CR and eTRIKS). I see the CDISC Europe Foundation as a spring board to strengthen and expand relationships with existing European members as well as forging new relationships.” Through the CDISC Europe Foundation, CDISC now has the opportunity to be a full partner in IMI projects. Through the MOU with IMI, all of the non-profit and academic organizations and SMEs participating in IMI projects also receive the benefits of a CDISC Platinum membership. CDISC has provided training to representatives of the majority of the IMI projects through its course: “A Global Approach to Accelerating Medical Research.” Another such training session is planned later in 2012 for those who missed the one in 2011.

Another area of expansion for CDISC in Europe will be in field of therapeutic area standards development. In the United States, CDISC has had a very important relationship with the National Cancer Institute (NCI) for nearly a decade. For example, NCI standard data collection forms are aligned with CDISC’s CDASH standard and NCI hosts the controlled terminology for CDISC and FDA. It is beneficial to now have a similar European network (EORTC) focused on the area of Oncology that is interested in implementing current CDISC standards as well as being involved in further work to establish new standards in this area.

“We look forward to building upon these European opportunities and having an excellent turnout at our CDISC European Interchange in Stockholm in April” said CDISC Board Chair Paula Brown Stafford of Quintiles. “As a leader in a global clinical research organization that services research efforts across the entire spectrum, it is critical to ensure that Europe is integrally involved in our global strategic goals, including translational research, for CDISC in 2012 and beyond.”

About CDISC

CDISC is a 501(c)(3) global non-profit charitable organization, with nearly 300 supporting member organizations from across the clinical research and healthcare arenas. The CDISC Europe Foundation is a European non-profit entity. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC innovations can decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.

Following the charter of the Board of Directors, we will also appoint new members of the Executive Committee of the Board. Dr. Frank Rockhold will become Past-Chair while Paula Brown Stafford takes the helm as Chair of the CDISC Board of Directors. “I look forward to utilizing my clinical research experience to assist the CDISC team achieve its vision of Informing patient care and safety through higher quality medical research and to meet the strategic goals of the CDISC Board for 2012-2015,” stated Ms. Brown Stafford. The new Chair-Elect will be Dr. Pierre-Yves Lastic. Dr. Edward Helton will complete his term as Past-Chair and his service on the Executive Committee; CDISC is extremely grateful for his many years of Board service to CDISC.

The CDISC Advisory Board (CAB) will also have new leadership in 2012 as Lauren Shinaberry assumes the role of Chair of the CAB and David Handelsman comes in as CAB Chair-elect. We sincerely thank Mr. Dave Evans who is stepping down as CAB Chair. In addition, CDISC is extremely pleased to welcome Mr. Wayne R. Kubick, who will assume the position of CDISC Chief Technical Officer in January 2012. “I am absolutely thrilled to finally have this opportunity to contribute full-time to CDISC, which has been a passionate area of interest for me over the past 12 plus years,” Mr. Kubick articulated. “I am eager to begin as we face continued challenges to further establish our foundational standards while also moving toward a new semantic infrastructure to advance research and improve interoperability with healthcare systems.”

“I am excited to welcome these new team members to the board,” stated Frank Rockhold. “They will undoubtedly add invaluable expertise to the ongoing efforts of the CDISC team, and I am optimistic about the future of CDISC under the direction of Ms. Brown Stafford and Dr. Kush.”

Biosketches:

C. David Hardison, Ph.D. is Managing Director of Health Sciences for Recombinant Data Corporation, responsible for their global biopharmaceutical business. In this general manager role, he is currently focused on establishing Recombinant’s European operations and facilitating the adoption of tranSMART, Recombinant’s Translational Research platform, throughout the biopharmaceutical, academic research, and patient-led disease communities. Dr. Hardison is a seasoned executive with over 30 years experience working as a team builder and change agent at the intersection of biopharmaceuticals, health care delivery, performance improvement, and information technology in both executive and board-level roles. In addition to his current role with Recombinant, Dr. Hardison has a long history of experience with such organizations as SAIC, First Consulting Group, Inc., Carolina Medicorp, Inc. (now Novant Health), Hospital Corporation of America, and Lilly. Previously, he served as CDISC Chairman from 2005-2007.

Robert R. Goodwin, MS, MBA is Vice President and WW Head, Safety, Evaluation and Reporting in the World Wide Safety and Regulatory Operations at Pfizer Pharmaceuticals. Mr. Goodwin brings over 19 years of experience in all facets of clinical operations including statistics, data acquisition, reporting and pharmacovigilance. He has established a track record of achieving cost reductions while increasing productivity through restructuring, process transformation and system reengineering, utilizing methods such as Lean and Six Sigma. Mr. Goodwin has held numerous positions within Pfizer Pharmaceuticals, Bayer Corporation, and the VA Medical Center in diverse roles, beginning as a biostatistician to current management roles in Pharmacovigilance.

Pierre-Yves Lastic, Ph.D. is currently Senior Director of Data Privacy and Healthcare Interoperability Standards at Sanofi. Dr. Lastic has over 20 years of experience in diverse management positions in the field of clinical research, leading clinical data management, biostatistics, clinical operations and clinical information management teams with Ciba-Geigy (Switzerland), Synthelabo, Sanofi-Synthelabo, and lastly with Sanofi-Aventis (France). He is specialized in the development and implementation of standards for the exchange of information in the healthcare area and is a member of the Personal Data Protection Committee of Sanofi-Aventis. Dr. Lastic has also previously served on the CDISC Board during an earlier term and currently chairs the European CDISC Coordinating Committee. Dr. Lastic is also a member of the BoD of the International Pharmaceutical Privacy Consortium (IPPC). He is furthermore a member of the Advisory Council Europe of the Drug Information Association (DIA), as well as a member of the Knowledge Management Group of the European Innovative Medicine Initiative (IMI). He is one of the experts on the European Medicine Agency’s (EMA) EudraVigilance Expert Working Group and EudraCT Joint Operations Group.

Wayne Kubick, MBA has over 25 years of experience in clinical research and drug safety, including executive management and strategy development. He has most recently worked for Oracle Health Sciences as Sr. Director of Product Strategy, and previously as Sr. Vice President for Lincoln Technologies/Phase Forward. Mr. Kubick has held several leadership positions with CDISC since 1999, as an original and current Board member, CDISC Technical Director and team leader; he led the development of the CDISC Study Data Tabulation Model (SDTM) for regulatory submissions and other standards efforts.

ABOUT CDISC

CDISC is a global, open, multidisciplinary, neutral non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical/medical research data and metadata through a consensus-based process. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. The CDISC Vision: Informing patient care and safety through higher quality medical research. CDISC standards are open and freely available via the CDISC website. Additional information on CDISC can be accessed at www.cdisc.org

Brussels – 15 December 2011 – The Innovative Medicines Initiative Joint Undertaking (IMI) and the Clinical Data Interchange Standards Consortium (CDISC) are pleased to announce that they have signed an agreement and initiated activities to enhance the use of information gathered for the purpose of developing safer, more effective innovative medicines for patients. The agreement was spearheaded by Ann Martin, Principal Scientific Manager for Knowledge Management at IMI. “To effectively manage information across a variety of projects requires a common format at the elemental level,” stated Ms. Martin. “Our stakeholders felt strongly that it is good practice to adopt data standards. CDISC already provides such standards enjoying wide adoption in the pharmaceutical industry. The CDISC standards therefore could be considered as a default standard for research conducted through the IMI projects. Moreover, CDISC not only focuses on global clinical research, but also collaborates to harmonise with global healthcare standards bodies such as the International Organization for Standardization (ISO), Health Level Seven International (HL7) and the European Committee for Standardization (CEN) through a Joint Initiative Council (JIC).”

IMI, a joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA), is the world’s largest public-private partnership initiative aiming to speed up the development of better and safer medicines. With its €2 billion research fund, IMI supports collaborative projects through consortia comprising academic experts, small and medium-sized enterprises, patients’ organisations, pharmaceutical companies, and regulators to support innovation in research and development in Europe. The IMI projects range from finding new biomarkers for the development of safer and more effective treatments for patients, to educating researchers and using electronic health records for various research purposes.

CDISC has developed consensus-based data formats that provide a common global ‘language’ and enablers for obtaining, using and sharing information to enhance science and improve research and healthcare. The CDISC suite spans the research process from the study plan (protocol) through data analysis and reporting. CDISC also provides enablers for using electronic health records (EHRs) for research. CDISC has become increasingly involved during the past few years in developing data formats to support specific disease areas such as tuberculosis (working with the TB Alliance, Gates Foundation and Critical Path Institute), Alzheimer’s disease, Parkinson’s disease, pain, oncology and other such therapeutic areas.

The agreement between CDISC and IMI provides CDISC education and materials for IMI consortia members, as well as a CDISC membership and access to the CDISC Members Only Area and portals for all academic institutions, small and medium-sized enterprises and other organisations receiving IMI funding in IMI projects. The EFPIA partners involved in IMI projects are already CDISC members. IMI project teams will use CDISC formats and standards where applicable and, when not available, they will participate in developing new ones.

“CDISC is extremely pleased to formalise this relationship with IMI,” said Dr. Rebecca Kush, President and CEO of CDISC. “We have thoroughly enjoyed working with IMI to date, and we feel that this will be an invaluable mutually beneficial partnership that can generate standards-based innovations to streamline the development of new therapies and medical knowledge that will benefit patients worldwide.” CDISC is also now a full participant in several IMI consortia through its CDISC Europe Foundation.

IMI Executive Director Professor Michel Goldman commented: “The agreement between IMI and CDISC will greatly enhance the standardisation of data management in IMI projects, and will therefore help IMI to achieve its goal: speeding up the development of more effective and safer treatments for patients. As IMI projects will be more and more based on the analysis of large data sets, the harmonisation and standardisation of data made possible through the collaboration with CDISC will be critical to the success of IMI.”

This partnership will allow IMI and CDISC to further develop tools that will advance the development of better and safer treatments for patients. In addition, their collaboration will open new opportunities for a wider number of public and private organisations in the healthcare sector and research industries to collaborate. The partnership broadens the adoption and use of common CDISC standards, and facilitates the harmonisation and cross-utilisation of clinical data, thus advancing higher quality medical research and leading more rapidly to innovative and effective cures.

ABOUT IMI

The Innovative Medicines Initiative (IMI) is the world’s largest public-private partnership in drug research. By linking industry, academic teams, regulators and patients’ organisations in joint research and training projects, IMI is transforming the EU’s ecosystem for pharmaceutical R&D, making Europe a more attractive place for private investment in innovation. By sharing research results that have not been brought together previously, IMI project partners are building new methods, models and tools that will speed up the development of novel therapies. IMI is funded jointly by the European Union (€1 billion in cash) and EFPIA, the European Federation of Pharmaceutical Industries and Associations (€1 billion in in-kind contributions). www.imi.europa.eu

ABOUT CDISC

The Clinical Data Interchange Standards Consortium (CDISC) is a global, open, multidisciplinary, neutral non-profit organisation that has established standards to support the acquisition, exchange, submission and archive of clinical/medical research data and metadata through a consensus-based process. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. The CDISC Vision: Informing patient care and safety through higher quality medical research. CDISC standards are platform-independent and freely available via the CDISC website. Additional information on CDISC can be accessed at www.cdisc.org.

Austin, TX, 19 October 2011 - Critical Path Institute (C-Path) and Clinical Data Interchange Standards Consortium (CDISC) announced the release of version 1.0 of the Alzheimer’s disease (AD) Therapeutic Area Standard (SDTM AD/Mild Cognitive Impairment User Guide). This was developed for the clinical research community to facilitate analysis and learning from clinical studies for treatment or prevention of AD.

The User Guide outlines a standardized set of data elements so that pharmaceutical companies and other medical researchers can more easily, and consistently, collect data that can be reliably pooled and compared.

Lynn Hudson, PhD, C-Path’s Chief Scientific Officer and Executive Director of C-Path’s Coalition Against Major Diseases (CAMD) noted, “Ultimately, this will result in increased efficiencies so that the U.S. Food and Drug Administration (FDA) and other regulatory agencies can more quickly and accurately review new applications for AD therapies, making it possible for medicines to reach patients more quickly and with greater assurances of safety and effectiveness.”

This is an early and landmark outcome from a joint C-Path/CDISC project to formalize and publish the CDISC AD standard based on the elements used in CAMD’s groundbreaking AD data repository. Collaborators in CAMD, which include global stakeholders from C-Path, CDISC, the AD clinical community, the pharmaceutical industry, government agencies, academia, and patient advocacy associations, reached consensus on the relevant pooled data domains, terminology, and definitions.

Early last year, seven of CAMD’s member organizations agreed to share their data from eleven recent AD clinical research studies and allowed it to be standardized, pooled, and made available to qualified researchers around the world. They invested significant in-kind resources to remap the retrospective data to the new format that is now the CDISC standard. Those organizations included Abbott Laboratories, Alzheimer’s Disease Cooperative Study, AstraZeneca Pharmaceuticals LP, GlaxoSmithKline, Johnson & Johnson, Pfizer, and sanofi-aventis. C-Path worked with another collaborator, Ephibian, a Tucson, Arizona-based company that specializes in software development, databases, web solutions and information security, to build a secure online data repository.

Today, the database contains data from over 4,100 AD subjects mapped to the CDISC standard. Its level of detail and scope will enable researchers to more accurately project the course of mild cognitive impairment (MCI) as it progresses to AD, thereby enabling the design of more efficient clinical trials that have the maximum chance of demonstrating whether a new treatment is truly safe and effective.

CAMD members and scientists around the world use the database to develop mathematical models to better track the course of MCI and AD in patients generally, as well as in genetically-defined subsets.

Roughly 5.3 million people in the U.S. alone are afflicted with AD, with costs reaching as much as $175 billion annually. Worldwide, it afflicts 30 million people, a number that is expected to quadruple by 2050. Halting or slowing the progression of this disease will prevent untold suffering and save tens of billions of dollars every year. “Pooling clinical data is a powerful way to gain new insights and leverage the efforts of companies that are developing new therapies,” said Raymond Woosley, MD, PhD, President and CEO of C-Path. “Scientists around the world can now use the combined, standardized data from clinical trials to better understand the true course of Alzheimer’s disease in patients.”

According to Rebecca Kush, PhD, President and CEO of CDISC, “Standards are essential to ensure that data can be aggregated for high quality research and robust analyses. Their value to companies and scientists increases substantially when they are used at the earliest stages of planning for a clinical trial, in the preparation of the protocol and the case report forms (including eCRFs). Adoption of core CDISC standards and the complementary new AD supplement, will enable far more rapid launch of clinical research studies of AD, and will also minimize or eliminate costly back-end data remapping (legacy data conversion). We are delighted to work with C-Path on this project and look forward to similar initiatives for additional therapeutic areas.”

Bron Kisler, Vice President of Strategic Initiatives of CDISC, pointed out that data standards will promote efficiencies in making progress against this disease. “If one trial cannot be reliably compared to another, we lose valuable information and often repeat costly mistakes. It would be like trying to accurately compare distances when they are variably represented and recorded in miles, kilometers, leagues, yards, and light years. If we are ever going to stave off Alzheimer’s disease, we need to be able to clearly study and learn from every piece of data.”

ABOUT CRITICAL PATH INSTITUTE (C-PATH): An independent, non-profit organization established in 2005 with public and private philanthropic support from the Southern Arizona community, Science Foundation Arizona (SFAz), and the U.S. Food and Drug Administration (FDA), C-Path is committed to improving health and saving lives by accelerating the development of safe, effective medicines. An international leader in forming collaborations around this mission, C-Path has established global, public-private partnerships that currently include over 1,000 scientists from government regulatory agencies, academia, patient advocacy organizations, and thirty five major pharmaceutical companies. C-Path is headquartered in Tucson, Arizona, with offices in Phoenix, Arizona, and Rockville, Maryland. For more information, visit www.c-path.org and follow us on Facebook. Click here to view a video showing why the work of C-Path is essential.

The C-Path Vision: Creating collaborations that advance scientific innovations to improve human health and save lives by accelerating the development of safe, effective medicines.

ABOUT CDISC: The Clinical Data Interchange Standards Consortium (CDISC) is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata to streamline clinical research. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website. Additional information on CDISC can be found on the CDISC website at www.cdisc.org.

The CDISC Vision: Informing patient care and safety through higher quality medical research.

ABOUT CAMD: C-Path’s Coalition Against Major Diseases is a unique public-private collaboration of pharmaceutical companies, patient advocacy/voluntary health associations, and government research and regulatory agencies formed to share pre-competitive data and knowledge that will more efficiently and safely speed development of new therapies and preventions for Alzheimer’s, Parkinson’s, and other debilitating neurodegenerative diseases. CAMD[RK1] works to provide tools that will help scientists identify clinical and laboratory characteristics of patients who are pre-symptomatic, and therefore most likely to benefit from new therapies. For more information on CAMD, visit http://www.c-path.org/CAMD.cfm.

CAMD MEMBERS: Abbott Laboratories, Alliance for Aging Research, Alzheimer's Association, Alzheimer's Foundation of America, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Eisai Inc., Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Forest Research Institute, Genentech Inc., GE Healthcare, GlaxoSmithKline, Johnson & Johnson, Michael J. Fox Foundation, National Health Council, Novartis Pharmaceuticals Corporation, Orion Corporation, Pfizer, Inc., sanofi-aventis US Inc., and Teva Pharmaceutical Industries, Ltd.

Work has already been initiated on standards development in certain of these areas that will form the basis of the Colloquia themes: TB, Virology (Hep C/Hep B/HIV), Pain, Oncology, Diabetes, Imaging. At the CDISC Interchange, representatives of FDA’s Center for Drug Evaluation and Research (CDER) will be available to discuss their assessment of therapeutic area standards and additional standards that are needed to support upcoming eSubmissions. CDISC has developed standards to support a core set of data that are essential across all clinical research studies. However, standards specific to determinations of efficacy and other specialty areas are still in development. This requires input from those with experience in these disease areas – clinicians and patients.

The Colloquia will be made possible through the support of Critical Path Institute (C-Path), the Association of Clinical Research Professionals (ACRP) and CDISC. C-Path will partner with CDISC to lead the colloquia and provide standards development expertise, and ACRP will invite participation of experienced clinicians. Additional active participation will be sought from the patient and clinical research arenas.

According to Raymond Woosley, MD, PhD, President and CEO of C-Path, “In order to facilitate more efficient development of new therapies, we must establish disease-specific standards for data collected in clinical research, as well as for eSubmission of that data for regulatory review. The data standards established by CDISC make it possible for scientists to communicate and share data and knowledge efficiently, creating an increased likelihood that new therapies will move more quickly and reliably through the regulatory review process and reach the patients who need them.”

 “ACRP is excited to be involved in this important endeavor that will directly affect its membership in the future,” said James Thomasell, Executive Director of ACRP. Paula Brown Stafford, Chair-elect for the CDISC Board of Directors, stated “The development of these important standards for efficacy data in clinical research is a key strategic focus area for CDISC from 2012-2015.”

Interested parties can obtain criteria for participation in the Colloquia and further information at the following link. The program and registration opportunities for the CDISC Interchange and associated educational events can be found at http://www.cdisc.org/interchange?a=2437#2437.

ABOUT CDISC

The Clinical Data Interchange Standards Consortium (CDISC) is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata to streamline clinical research. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website. Additional information on CDISC can be found on the CDISC website at www.cdisc.org.

The CDISC Vision: Informing patient care and safety through higher quality medical research

ABOUT Critical Path Institute (C-Path)

An independent, non-profit organization established in 2005 with public and private philanthropic support from the Southern Arizona community, Science Foundation Arizona (SFAz), and the U.S. Food and Drug Administration (FDA), C-Path is committed to improving health and saving lives by accelerating the development of safe, effective medicines. An international leader in forming collaborations around this mission, C-Path has established global, public-private partnerships that currently include over 1,000 scientists from government regulatory agencies, academia, patient advocacy organizations, and thirty five major pharmaceutical companies. C-Path is headquartered in Tucson, Arizona, with offices in Phoenix, Arizona, and Rockville, Maryland. For more information, visit www.c-path.org. Click here to view a video showing why the work of C-Path is essential.

ABOUT ACRP

The Association of Clinical Research Professionals (ACRP) is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. ACRP was founded in 1976 to address the educational and networking needs of research nurses and others who supported the work of clinical investigations. With its own professional society came the recognition of a new distinctive profession — that of the clinical researcher. More than 35 years later, ACRP is a global association comprised of more than 18,000 individuals in over 65 countries dedicated to clinical research and development. Our mission is “To provide global leadership to promote integrity and excellence for the clinical research profession”. The Academy of Pharmaceutical Physicians and Investigators (APPI) is an affiliate of ACRP and is the leading professional organization, exclusive to physicians, that supports and addresses the unique issues and challenges of all physicians involved in clinical research.

An opening keynote presentation on a Learning Healthcare System will be delivered by Dr. Charles Friedman, Professor and Director of the Health Informatics Program in the Schools of Information and Public Health at the University of Michigan and formerly Chief Scientific Officer from the U.S. Office of the National Coordinator (ONC) of Health Information Technology. This keynote will be preceded by an opening statement from CDISC Board Chair, Dr. Frank Rockhold.

”CDISC is pleased to host this important and popular International Interchange to further their important work in streamlining the clinical research process to improve patient care and safety”, stated Dr. Rockhold. “The theme ‘Standards for Patients’ is particularly appropriate since researchers can only properly and morally serve the patients who participate in clinical research if they can make good use of the data for the purpose of learning. That is the value of standards.”

The opening keynote on Thursday, 13 October will be delivered by Dr. Greg Koski, Senior Scientist, James Mongan Institute for Health Policy and a Harvard Medical School Professor, who will speak about a new initiative for streamlining global clinical trials. Dr. ShaAvhree Buckman, Director of the Office of Translational Sciences in CDER/FDA, will present an FDA keynote on Thursday afternoon, prior to the annual Interchange FDA Panel Discussion. The CDISC Advisory Board dinner meeting on 11 October will include an FDA Town Hall, and the therapeutic area specific Colloquia will occur earlier that day and on 14 October.

CDISC would like to thank Oracle for their global CDISC Interchange support along with SAS, McDougall Scientific and Percept Pharma Services for their dedication and commitment to CDISC by sponsoring the 2011 CDISC North American Interchange. The Colloquia will be supported by CDISC, the Critical Path Institute and the Association of Clinical Research Professionals (ACRP/APPI). We would also like to thank our Media Partners: Touch Briefings, PhUSE, DIA, and the Critical Path Institute.

For a full program and registration for the Interchange go to http://www.cdisc.org/interchange.

ABOUT CDISC

CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata to streamline clinical research. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website. Additional information on CDISC can be found on the CDISC website.

The CDISC Vision: Informing patient care and safety through higher quality medical research

Dr. Kush was selected to fulfill a requirement of the Department of Health and Human Services (HHS) to appoint a member from the research community to the HIT Standards Committee. The term of this appointment is May 2011 to June 2013.

"The implementation of informatics standards across the continuum of care delivery to clinical research to data archiving and analysis is essential for cost effective and precise progress in health diagnostics, prevention and therapeutics,” states Steven Hirschfeld, MD, PhD, Captain U.S. Public Health Officer, Operations Chief and Chief Medical Officer, USPHS Rapid Deployment Force-1 and Associate Director for Clinical Research and Acting Director, National Children’s Study, Eunice Kennedy Shriver National Institute of Child Health and Human Development. “Dr. Rebecca Kush is ideally qualified for advancing these goals and providing high quality and objective perspective based on her international experience, her leadership, track record and vision."

Rebecca Kush is currently President and CEO of the Clinical Data Interchange Standards Consortium (CDISC), an open, global standards developing organization that has concentrated on developing standards to support medical research and related areas of healthcare for the past 14 years. Dr. Kush has over 30 years of experience in the area of clinical research, including positions with the U.S. National Institutes of Health, academia, a global clinical research organization and biopharmaceutical companies in the U.S. and Japan. She earned her doctorate in Physiology and Pharmacology from the University of California San Diego (UCSD) School of Medicine. She has served on the Board of Directors for the U.S. Health Information Technology Standards Panel (HITSP), Drug Information Association (DIA) and currently Health Level Seven (HL7) and was a member of the advisory committee for the WHO International Clinical Trials Registry Platform. Dr. Kush has served on appointed committees for the Institute of Medicine, provided expert input to the President’s Council of Advisors on Science and Technology (PCAST) and has authored numerous publications for books and journals, including New England Journal of Medicine and Science Translational Medicine.

Dr. Kush was also recently invited by Dr. Harold Varmus to present at the NCI Director’s Industry Liaison Group and to serve as a domain expert on the caBIG Oversight Ad hoc Subcommittee of the National Cancer Institute, Board of Scientific Advisors. The purpose of the Ad hoc subcommittee is to evaluate the scientific merit of the caBIG Program’s ongoing and planned initiatives and to advise the NCI Board of Scientific Advisors (BSA) and the NCI Director about steps that should be taken to improve the caBIG program and to enhance its utility for current and future users of the program.

"On behalf of the CDISC Board of Directors, I would like to thank Becky for her continued commitment to standards in medical research”, said Paula Brown Stafford, Chair-elect of the CDISC Board of Directors and President of Clinical Development, Quintiles. “As the CEO of CDISC she represents over 300 member organizations and will be able to work on their behalf through this new appointment."

ABOUT CDISC

CDISC is a global, open, multidisciplinary, neutral non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC Healthcare Link Initiative collaborates to link research and healthcare through standards-inspired innovation to further the CDISC mission and vision. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. The CDISC Vision: Informing patient care and safety through higher quality medical research. CDISC standards are global, vendor-neutral, platform-independent and freely available via the CDISC website. Additional information on CDISC can be found on the CDISC website at www.cdisc.org.

Methods   Proof-of-concept study involving 26 clinicians given access to EHR-based ADE reporting functionality from December 2008 to May 2009.

Measurements  Number and content of ADE reports; severity of adverse reactions (clinician and computer algorithm defined); clinician survey.

Results  During the study period, 26 clinicians submitted 217 reports to the FDA. The clinicians defined 23% of the ADEs as serious and a computer algorithm defined 4% of the ADEs as serious. The most common drug classes were cardiovascular drugs (40%), central nervous system drugs (19%), analgesics (13%), and endocrine drugs (7%). The reports contained information, pre-filled from the EHR, about comorbid conditions (207 reports [95%] listed 1899 comorbid conditions), concurrent medications (193 reports [89%] listed 1687 concurrent medications), weight (209 reports [96%]), and laboratory data (215 reports [99%]). It took clinicians a mean of 53 seconds to complete and send the form. In the clinician survey, 21 of 23 respondents (91%) said they had submitted zero ADE reports to the FDA in the prior 12 months.

Conclusions  EHR-based, triggered ADE reporting is efficient and acceptable to clinicians, provides detailed clinical information, and has the potential to greatly increase the number and quality of spontaneous reports submitted to the FDA. Copyright # 2010 John Wiley & Sons, Ltd.

Click here for full article. And see the following link for Commentary

“CDISC has been a leader in demonstrating the value of EHRs in the research arena,” stated Dr. Doug Fridsma, Director, Office of Interoperability & Standards at the U.S. HHS Office of the National Coordinator for Health IT (ONC).  “Linking clinical care with clinical research sets the stage for novel ways of leveraging patient care information using more granular metadata approaches.”

The currently available solution is being demonstrated by EHR vendors along with clinical trial technology and service providers, CDISC and HIMSS at DIA 2011 in Chicago on June 19-23.  DIA 2011 provides educational and networking opportunities to more than 8,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products.

“We are very pleased to partner with DIA and CDISC to feature the profiles from the Quality Research and Public Health domain of IHE.  This is a valuable opportunity to share the HIMSS Interoperability Showcase^TM  with research stakeholders,” said H. Stephen Lieber, CAE, HIMSS President and CEO of HIMSS.

CDISC has been working with the IHE Committee on Quality Research and Public Health (QRPH) for the past 7 years to develop the necessary integration profiles to implement global standards such as CDISC and HL7.  The ANSI-sponsored Interoperability Specification (IS # 158), which provides a core standard research dataset from EHRs, was ratified by the Health Information Technology Standards Panel (HITSP) in 2010.  The development of this IS was conducted in a manner to ensure compliance with regulatory requirements for electronic source data, electronic record retention, patient privacy and data security, audit trails and the global Good Clinical Practices (GCP).   The concept behind this standards-based innovation is that data should be entered once for multiple purposes, thus improving quality and patient safety along with streamlining workflow such that a busy clinician can readily participate in research.

“This solution has the potential to revolutionize the research process,” said Landen Bain, CDISC Healthcare Liaison.  ”It is in use today, and the powerful simplicity includes the opportunity for medical sites with varying EHR systems (or even paper or EDC systems) to participate in the same research study, yet the resulting research data are provided in a standard format so that they can readily be aggregated into robust research databases to facilitate analysis, publications or eSubmissions to FDA in the preferred format to improve regulatory reviews.”

“We are excited to bring the HIMSS Interoperability Showcase to DIA so that those conducting research can appreciate this interesting and educational opportunity,” said Paul Pomerantz, Executive Director of DIA. “The event will include not only the continuous demonstration, but also presentations in the showcase area and an Interoperability Town Hall, moderated by CDISC President Dr. Rebecca Kush, with panelists from FDA and HHS/ONC.”

Participants

·         Premier Supporters:  Oracle and Quintiles

·         Contributor Network:  ASTER Safety Consortium, Duke Clinical Research Institute, HL7

·         Participant/Vendors:  Allscripts, Cerner Corporation, FDA/CDRH, Greenway Medical Technologies, IPL, Medidata Solutions, Nextrials, Oracle, Outcome, SAS Institute

·         Emerging Technology Participant:   CMIC Co., Ltd.

Visit the DIA Interoperability Showcase page for Details.

ABOUT CDISC

CDISC is a global, open, multidisciplinary, neutral non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. CDISC Healthcare Link Initiative collaborates to link research and healthcare through standards-inspired innovation to further the CDISC mission and vision.  The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. The CDISC Vision: Informing patient care and safety through higher quality medical research. CDISC standards are global, vendor-neutral, platform-independent and freely available via the CDISC website. Additional information on CDISC can be found on the CDISC website at www.cdisc.org.

ABOUT DIA
DIA is a nonprofit, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China. For more information visit: www.diahome.org.

ABOUT HIMSS

HIMSS is a cause-based, not-for-profit organization exclusively focused on providing global leadership for the optimal use of information technology (IT) and management systems for the betterment of healthcare. Founded 50 years ago, HIMSS and its related organizations have offices in Chicago, Washington, DC, Brussels, Singapore, Leipzig, and other locations across the United States. HIMSS represents more than 35,000 individual members, of which more than two thirds work in healthcare provider, governmental and not-for-profit organizations. HIMSS also includes over 520 corporate members and more than 120 not-for-profit organizations that share our mission of transforming healthcare through the effective use of information technology and management systems. HIMSS frames and leads healthcare practices and public policy through its content expertise, professional development, and research initiatives designed to promote information and management systems’ contributions to improving the quality, safety, access, and cost-effectiveness of patient care. To learn more about HIMSS and to find out how to join us and our members in advancing our cause, please visit our website at www.himss.org.  HIMSS Interoperability Showcases serve the healthcare community by promoting uptake of standards-based solutions that improve the potential for health information exchange between systems, providers, and organizations in order to optimize clinical care.

ABOUT IHE

IHE International, Inc. (www.ihe.net) is the global hub of the IHE initiative, a multi-stakeholder effort started in 1997 to promote the effective use of electronic health records and health information technology (HIT) by driving the adoption of standards-based solutions for interoperability. IHE International brings together HIT experts and stakeholders in more than a dozen clinical and operational domains to develop implementation guides call IHE Profiles that define the use of standards to address specific HIT interoperability needs. It also oversees a process of testing that fosters the adoption of IHE Profiles in real-world HIT products and care settings. IHE interoperability solutions are implemented in hundreds of products and in care sites around the world.

The FDA, which currently houses the largest known repository of high quality research study data on safety and efficacy of biologics, drugs and devices, has long awaited a database to support comparisons across similar products. However, this requires that data be provided in a standard format to enable rigorous analyses and comparisons. The Statement of Objectives in the solicitation for the CTR project specifies that the vendor will provide operational support for the processing of CDISC Study Data Tabulation Model (SDTM) data as well as for the incremental load and testing of legacy-converted datasets during the implementation effort. The SDTM standard was developed through a consensus-based process over the course of the last decade to support the electronic submission of clinical research data to FDA to facilitate their reviews of applications for the approval of new therapies.

In addition, the solicitation indicates that the new CTR will be compliant with appropriate standards, including the Biomedical Research Integrated Domain Group (BRIDG) Model. The BRIDG model was initiated by CDISC in 2004 and is now supported through a collaborative group that includes CDISC, Health Level Seven (HL7), NCI and FDA. It is a means of harmonizing across all of the CDISC standards that support biomedical research from protocol through analysis and reporting. The BRIDG model is now a CDISC standard, an HL7 standard and is entering its last ballot cycle to become an ISO/CEN standard through the Joint Initiative Council for global harmonization of standards.

“The FDA leadership is to be commended on their efforts to adopt standards that will improve their reviews of new applications for therapies and to develop a database to support regulatory science and cross-product analyses” stated Dr. Frank Rockhold, Chair of the CDISC Board of Directors “They are clearly striving to improve their processes for the benefit of public health.”

The request for proposals for the CTR states “the availability of this repository for organizing, and extracting scientific data about regulated products in a common "language" or format to support regulatory decision making underpins the success of any broader initiatives to comparatively evaluate product performance. Such a data repository will be developed during this project”.

For more information, please see: https://www.fbo.gov/index?s=opportunity&mode=form&id=3f9ce599bf3d89c4bdd18651d9d68ebb&tab=core&_cview=1

ABOUT CDISC

CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website. Additional information on CDISC can be found on the CDISC website at www.cdisc.org. The CDISC Vision: Informing patient care and safety through higher quality medical research

The CDISC Board of Directors is made up of 12 members, each serving a three-year term. Elections are held annually for vacant seats and new members begin their terms on 1 January. Board membership requires people who care about the organization, are willing to offer their time and expertise, enjoy being in a leadership role, and want to contribute to enable information system interoperability to improve medical research and related areas of healthcare. The Board has monthly 1½ hour teleconferences as well as quarterly in-person meetings that usually last 1½ days.

The role of the Board of Directors is to focus on the governing functions of the organization (functions that provide the direction, resources and structure to meet its mission). The Board does not operate the day-to-day business of the organization. Although the Board delegates operational responsibilities to staff and/or members, it is responsible for ensuring that the organization's resources are being appropriately applied to meet its mission, guiding the organization into the future, and ensuring the continued success of CDISC.

The nominations will be reviewed by the CDISC Governance Committee and a slate of candidates will be presented to the CDISC Advisory Board (CAB) and the CDISC Board of Directors. The open positions are for the term beginning 1 January 2012, with one being elected by the CAB and the other position(s) being elected by the current Board of Directors.

CDISC's future depends upon the active participation of our CDISC community and the forward-thinking leadership of the Board of Directors. Please nominate those persons whom you believe will serve the organization well. Thank you for your nominations!

 Kindest regards,

Edward Helton, PhD

CDISC Governance Committee Chairman

Ann Martin, Principal Scientific Manager and Statistician, is responsible for the Knowledge Management aspects of the research collaborations of the Innovative Medicines Initiative (IMI), a public-private partnership between The European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Ann is responsible for developing and implementing the IMI Knowledge Management Strategy, including the data processing infrastructure, document management and e-collaboration platforms. She will speak in the Closing Plenary session of the CDISC Interchange. Ms. Martin commented, "a major bottleneck in drug development is the effective sharing of data for translational research. The key to address the hurdle lies in the consensus around standards for research, clinical and healthcare data. Only then will we be able to gain the insights for faster and more efficient discovery and development of safe and effective medicines for patients".

Dr. Pierre-Yves Lastic, Chairman of the European CDISC Coordinating Committee (E3C), will reminisce on 10 years of CDISC in Europe. Dr. Lastic served as a Director on the CDISC Board of Directors for the two-term (6 year) limit, and he continues as an ex-officio member in his role as leader of the E3C. “I am very pleased with the program that the E3C has organized for its European CDISC Interchange this year”, states Dr. Lastic, “In addition to excellent keynotes and plenary speakers, there are numerous presentation slated to demonstrate the value of the CDISC standards in improving the medical research process to bring new therapies to patients sooner”.

On 11, 12 and 15 April, there will be CDISC authorized training courses, including ‘A Global Approach to Accelerating Medical Research’ and courses on the suite of CDISC standards that facilitate clinical research studies from protocol through analysis and reporting. The evening networking event will be held at the Brussels Comic Strip Center. The CDISC Board of Directors will hold its Annual Meeting on 11-12 April in Brussels just prior to the Interchange.
CDISC would like to thank Oracle Health Sciences for their sponsorship of all the CDISC Interchange events in 2011 and our Patron Absolute Clinical Data Systems in China. Future CDISC Interchanges are scheduled in Japan on 12 – 15 July 2011 and in North America (Baltimore) on 10 – 14 October 2011.
For more information or to register, please see: http://www.cdisc.org/interchange.

ABOUT CDISC
CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website. Additional information on CDISC can be found on the CDISC website at www.cdisc.org.

The CDISC Vision: Informing patient care and safety through higher quality medical research

The role of the BRIDG BoD is to focus on the governing functions of the BRIDG model (functions that provide the direction, resources and structure to meet its mission).  The BRIDG BoD has monthly one hour teleconferences as well as in-person meetings as needed (usually no more than one per year).

The BRIDG Board of Directors is made up of 7-11 members. Four members are appointed by the four founding stakeholders (NCI, CDISC, HL7 RCRIM, FDA).  The remaining Board Members are elected by vote of the sitting Board members.  The BRIDG BoD Charter can be found here.  The current Board membership can be found here.

Elections are held annually for vacant seats and new members begin their terms on 1 January.  The nominations will be reviewed by the current BRIDG BoD, who will then elect one new member.  The open position is for the term beginning 1 January 2011 and ending 31 December 2013.

The BRIDG model’s future depends upon the active participation of the community and the forward-thinking leadership of the BRIDG BoD.  Thank you for your nominations!

If you have any questions, please contact Julie Evans at jevans@cdisc.org.

The US National Cancer Institute – Enterprise Vocabulary Service (NCI-EVS) has a long tradition of working with partners to create and publish controlled terminology and has collaborated with CDISC since 2004 to develop and publish CDISC controlled terminology for the entire suite of CDISC standards (e.g. the SDTM, CDASH, SEND, etc.).  NCI has agreed to include CDISC SHARE system requirements in the development of their enhanced semantic infrastructure. 

Dave Iberson-Hurst, CDISC Technical Architect said, “CDISC is moving from the world of implicit understanding to the world of the explicit understanding”. CDISC SHARE will facilitate this novel approach to developing machine-readable clinical metadata standards. Frank Rockhold, Chair of the CDISC Board of Directors, stated, “SHARE is a significant shift in the way that CDISC will create its standards and will allow for acceleration in the development of new therapeutic area standards. The first release will contain the existing SDTM and CDASH standards and should be available for use in the second half of 2011 with new content following shortly after. This is an important step in the evolution of a content standard which will improve our ability to use research data to help patients in the future.”

About CDISC: CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.  CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website.  Additional information on CDISC can be found on the website at www.cdisc.org.

About The National Cancer Institute – Enterprise Vocabulary Services: NCI-EVS provides a set of services and resources, including NCI Thesaurus and NCI Metathesaurus, that facilitate the standardization of terminology across the Institute and the larger biomedical community.  Terminology plays an important role in NCI's research, clinical, and information efforts. NCI is working with many partners to create and publish controlled terminology that can help develop and communicate information useful to scientists, clinicians, patients, and the public.

Dr. Fridsma completed his medical training at the University of Michigan in 1990, and his PhD in Biomedical Informatics from Stanford University in 2003.  His research interests include the development of computational tools to study patient safety, clinical work processes, and methods to improve model-driven standards development processes. He has served on the Clinical Data Interchange Standards Consortium (CDISC) Board of Directors from 2005-2008, and was appointed to the HIT Standards Committee in 2009. He recently resigned from the HIT SC to become the acting director of the Office of Interoperability and Standards at ONC. He is currently on leave from the Department of Biomedical Informatics at Arizona State University and from his clinical practice at Mayo Clinic Scottsdale.

Dr. Mullin directs strategic planning and business informatics for FDA CDER. The Office of Planning and Informatics plays a lead role in CDER long-range planning, budget formulation, program analysis, and informatics operations. In addition, Dr. Mullin has been appointed lead negotiator for FDA for the 2012 PDUFA reauthorization.  Dr. Mullin will speak at the CDISC Interchange on her leadership in the development of the CDER Data Standards Plan and other efforts that are coming into play within FDA to leverage the value of standards to improve the FDA review process.

Dr. Woosley founded C-Path, a non-profit corporation formed by the Food and Drug Administration, SRI International and the University of Arizona to develop scientific consensus on methods that accelerate the development of safe innovative medicines. He is currently on leave from the Department of Biomedical Informatics at Arizona State University and from his clinical practice at Mayo Clinic Scottsdale. In recent months, C-Path's Coalition Against Major Diseases (CAMD), a collaboration that includes CDISC and other organisations, released a database of more than 4,000 unidentified Alzheimer's disease patients who have participated in eleven industry-sponsored clinical trials. The CAMD collaboration is bringing greater speed, efficiency, safety and predictability to medical product development. 

The Program for this year’s event sees a new stream, ‘Standards and the Patient’ where CDISC is privileged to welcome Dr. Adam Clark (Faster Cures – formerly Lance Armstrong Foundation and NCI), Dr. Jeff Allen (Friends of Cancer Research) and Dr. Ron Perrone (Tufts University). They will be speaking about the need for standards to work with healthcare, in a translational science setting to benefit human health. In addition, the FDA will have good representation through the FDA panel and Dr. Vicki Seyfert-Margolis, Office of the Commissioner, will be presenting in the session dedicated to the FDA’s implementation plans.

This year’s Interchange also sees the new Round Table Discussion Groups making their debut in North America, following their success in Europe in April, as well as the most up-to-date CDISC education. The latest version of the Protocol Representation course has been carefully restructured to appeal to a wider audience and a brand new course, CDISC: A Global Approach to Accelerating Medical Research, will be launched at this conference. It is designed to demonstrate the true value of ‘implementing CDISC end to end’ and educate attendees on the real business solutions that can benefit any organisation in this arena.

Full details of the conference, including courses, registration and hotel accommodation can be found on the CDISC website: www.cdisc.org/interchange

ABOUT CDISC
CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.  CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website.

The work of the group is organised through the ESUG committee and a sign of our developing maturity is that, in the past 12 months, we have experienced our first turnover of “willing volunteers” to share the responsibility for organising and promoting our activities. 

This year, we have lost Jason Housley (Co-Chair) to an internal promotion and increasing responsibilities within the wider CDISC environment.  As a founder member of the group and an energetic promoter of the CDISC brand, we were sad to see Jason depart.  Equally, two other founder members of the committee, Donald Paterson and Stephen Harrison, also took their leave for reasons of work commitments and geographic relocation.  We wish them well and thank them for their significant contributions to the establishment of our group.

To balance the departures, we are delighted to have welcomed Jo McAllorum and Alan Cantrell to the committee, which now comprises 9 individuals, and who may be seen and contacted on our website under the Committee section.  This area, and other aspects of the Portal, is now receiving regular updates and improvements to increase their relevance and usefulness to our expanding network.

As this document goes to press, we are halfway through our schedule of events for 2010, having held a web conference call on DEFINE.XML in May and a Face-to-Face meeting at Brunel University in July.  Both events have been extremely well attended and in the latter case we were oversubscribed and had to implement a registration recycling system for reserved places which were subsequently not required.

Later in September, we have our second TC of the year entitled “CDISC SDTM Validation: How can we do it right? (general)” and we will round out our activities with a second Face-to-Face meeting in December.  Details of all of this and all past, present and future activities may be found at www.esug.org.uk.

Over the course of this year, the committee has worked hard to strengthen its relationship with the main body of the CDISC organisation.  This is now delivering significant added value to the ESUG community through the participation of senior CDISC representatives at our events and support for the administrative side of our activities.  All of this is very much appreciated.

At the beginning of the year, the committee established goals for the ESUG activities as a means of measuring the success of our efforts and to evaluate if the quality and appeal of what is offered is attracting a growing number of followers & supporters.  We will formally review our performance when our schedule of events has been concluded but the indications from the first half of our 2010 programme is that we are expanding our audience and providing relevant and high quality material to assist the English Speaking community with additional tools and knowledge to access and take advantage of the CDISC initiative.  This is very pleasing and a reassurance that the hard work put in by ESUG committee is appreciated by our growing list of contacts.

Why not get in touch with us and let us know your interest in all matters CDISC related.  Here’s how:

Register for an event by emailing: registrations@esug.org.uk
or
Contact the committee by emailing: committee@esug.org.uk

PGx SDTM Domains Review Package

The completion of the Human Genome Project in 2003 has heralded a new era representing a significant rise in the use of Pharmacogenomic (PGx) data in both research and clinical care.  It promises to be an exciting time to pursue greater understanding of molecular pathways and underlying disease risks in certain populations.  With this increased interest in PGx acting as a catalyst, the FDA started their innovative Voluntary Genomic Data Submission program also known as VGDS.  It recently was extended to also include exploratory data hence the new designation of VxDS. 

The PGx team (a sub-team within the CDISC SDS Team) has developed several domains designed to carry pharmacogenomics data. The development of these CDISC PGx domains was done in parallel  with the work being done by the HL7 Clinical Genomics Work Group, which was initiated jointly several years ago by CDISC and HL7.  Due to their prevalent use in research, the initial design focuses on Genetic Variation and Gene Expression.  

You can read the a full and detailed account of this project here and in the associated package, which includes the domains as well as some helpful PowerPoint presentations.   

CDISC Members are requested to review this package and provide comments on the proposed standard domains by 5 April 2010.   Please forward to others who may be interested in pharmacogenomics within your organizations.

What is the PRM V1.0?

The Protocol Representation Model Version 1 is a set of descriptive information about protocol concepts and how these concepts fit together.   This set of descriptive information is called a Domain Analysis Model (DAM), which is a structured framework for capturing data and process requirements for a topic. The protocol topic areas in PRM V1.0 are study design, eligibility criteria and study registries. 

Why is the PRM a DAM rather than a spreadsheet or dataset description?

The Protocol Representation Group (PRG), the team that developed the PRM, found that a DAM provided the ability to capture more information about the protocol concepts than a spreadsheet or dataset description.  This approach also allows for multiple implementations of this model using various technologies, e.g. an HL7 Version 3 message for Clinical Trial Registration, a CDISC ODM extension for Study Design, or a set of SDTM domains for Study Design.

Has the PRM been vetted?  If so, how?

The PRM V1.0 underwent the open, public CDISC review and comment process in 2009 in which about 250 comments were collected.  The PRG discussed each comment and determined how it should be handled:  Should the PRM be changed?  Should the comment be considered in a future version of the PRM?  Was the comment within the scope of the PRM?  Then the model was updated based on these decisions.  For results of this comment and review process, please see the spreadsheet posted here.

In addition to the CDISC PRM V1.0 review and comment process, the protocol concepts were also part of the CDISC public review of BRIDG Release 3.0 at the end of 2009.  The PRM V1.0 is a subset of BRIDG R3.0 concepts.  Additional comments were addressed during this review and the results are posted on the BRIDG page.

How is PRM V1.0 different from the BRIDG R3.0 Protocol Representation Sub-domain?

The PRM V1.0 is a subset (or "view") of BRIDG R3.0.  The Protocol Representation Sub-domain of BRIDG R3.0 is also a subset (or "view") of the larger BRIDG model.  Both of these subsets are similar, but the PRM V1.0 contains additional BRIDG concepts such as study registry information.  CDISC's scope for PRM V1.0 is slightly different from BRIDG's scope for the Protocol Representation Sub-domain.

Where can I find out more about the PRM V1.0?

The PRM V1.0 is available on the CDISC website.  More details about the model and its history are included in the document posted at this location.  

The new domains are:

1. Device Disposition: links a specific device to a specific subject
2. Device Tracking: tracks the movement of the device between sponsor and site and, if necessary, the site and the subject.
3. Device Properties: describes the characteristics of a device at the generic or model level (possibly also each component of a device)
4. Device Malfunctions: records the malfunctions of a specific device

In addition, further device elements have been identified for the following domains: Device Identification, Demographics, Drug Accountability, Subject Exposure and Subject Disposition.  These domains will be included in Device Package-2 that will be developed later in 2010.

In parallel, the CDASH collection fields are being identified to accompany these 4 new SDTM domains. The goal is to focus on the basic device data collection fields that are seen in the majority of device clinical trials. To achieve this goal, a CRF-Analysis sub-team was formed.  This group collected and reviewed ~ 170 device CRFs from 42 device companies to identify areas where devices differ from or are the same as drug studies. Interestingly, the results of this analysis reveal that the current CDASH domains and collection fields developed for drug trials meet almost all the requirements of medical device trials. The team is also looking at existing Controlled Terminology to identify any gaps that may require the development of device specific terminology.  Once this gap analysis is completed new terms will be requested according the terminology change control process located on the NCI EVS webpage.

The Team is now working to prepare the “initial consensus version” (ICV) that will include both the new SDTM and CDASH device-related domains and to begin the first review period described in the CDISC consensus process. This consensus process includes an internal CDISC review and an external focused review followed by an open public review period. Comments from each of these review cycles will be addressed prior to the release of the final standard.

The overall goal is for the new CDASH and SDTM device domains to be incorporated into a device standard by Q2 2010.

For further information about what Device team is doing, please contact:

Rhonda Facile, Carey Smoak, Kit Howard or Fred Wood.

In addition, following a rigorous process of selection, CDISC is pleased to announce that two highly qualified individuals will be added to its Board of Directors for a three year term (2010-2012).  Dr. Steven Hirschfeld and Wayne R. Kubick will have now been welcomed to the CDISC Board.  Sincere appreciation goes to Dr. Christopher Chute, who served his three year term on the CDISC Board but did not run again since he assumed the role of Chair, ISO TC 215 (Healthcare Standards) as of January 2010.  We look forward to continuing to work with Dr. Chute within ISO.   Dr. Pierre-Yves Lastic completed two 3 year terms on the CDISC Board, but will remain on the Board in an ex-officio capacity through his role as Chair of the European CDISC Coordinating Committee (E3C), which officially begins in April 2010.  William Rosen will be staying for one more year to complete a second term on the Board.

Dr. Steven Hirschfeld has recently become the Acting Director for the National Children’s Study at the National Institutes for Health, in Bethesda, MD and he also holds the position of Associate Director for Clinical Research at the National Institute of Child Health and Human Development. Dr. Hirschfeld brings a thorough knowledge of and first-hand experience with CDISC standards and their implementation.  He has been FDA Liaison to CDISC for Data Analysis, Adverse Event Analysis and Protocol Representation, with additional work on the CDISC Glossary.  In addition, he is a co-lead for the CDISC Integrated Safety Data Pilot work with the FDA. After gaining his MD at Columbia University, he began a distinguished career as a pediatrician at the University of California. Dr. Hirschfeld joined the FDA Center for Drug Evaluation and Research as a Medical Officer working in the Division of Oncologic Drugs and the Pediatric Program.  He also worked for the FDA Center of Biologics Evaluation and Research as a medical officer in the Office of Cellular, Tissue and Gene Therapy. 

Wayne Kubick has over 25 years experience, primarily involving clinical research, drug development and product safety, including executive management, strategy development, consulting and software development. He is currently Sr. Vice President and Chief Quality Officer at Phase Forward Lincoln Technologies. Mr. Kubick has vast consulting experience in clinical data architectures, product safety, data mining and analysis technologies, electronic regulatory submissions, information technology strategies, and business processes for clinical research. In addition, he has made major contributions to CDISC over the last 10 years bringing his expert knowledge to CDISC.  Wayne generated the initial strawman SDTM model (with Dave Christiansen) before CDISC was incorporated and served as a team leader for the SDS team and also on the first CDISC Board.  Wayne has also worked with the HL7 standards, regulatory processes and quality systems, EDC, CDMS, electronic publishing, database and analysis software applications.  We are glad to have him back ‘on Board’.

The skillsets and experience that these two new Board members will bring is complementary to and augments that already within the CDISC Board of Directors and will no doubt prove invaluable during their coming terms.  

The 2010 goals will be posted later this year due to an excellent opportunity to ensure that they are aligned with those of FDA CDER and CBER. In November and December 2009, FDA representatives met with the CDISC Board and Operations leaders;  others from FDA participated in the CDISC Interchange. Consequently, a key meeting with the CDISC Executive Committee and FDA representatives is scheduled for early February. We will be reporting more about this opportunity and the outcome of our coming discussions in future eNewsletters. In the interim, we already know some of the key drivers for 2010 and would like to outline those for you now.

Focus Area for CDISC 2010: 

This year, as a focus area, CDISC wants to encourage all organisations and their partners to adopt the CDISC standards at the “front end” of the medical research process i.e.-when a programme or study is being designed, “Use Standards from the Start”.  Why? Well it’s simple, by using standards from the start, you can gain the greatest benefits in terms of the time and cost savings and reap the highest quality data, an extremely valuable asset. Understandably, adoption of the Submission Data Standards has been the focus for many companies. However, CDISC now has a complete suite of standards that can be used right from the development of the protocol. Therefore, it seems sensible to collect standards the way we want to submit them, thus avoiding costly, time-consuming (and sometimes difficult mapping exercises) to do data conversions at the end of the process, prior to submission, when companies should be focusing on the science of their research.

With this in mind, below are current key drivers influencing the goals for CDISC in 2010:

• Drive adoption of and support new and existing standards (through technical, communications and education support) by emphasizing implementation at the ‘front end’ of the process (build in quality to reap the greatest benefits)
  • CDASH for case report forms as a path to reporting and submission
  • Protocol Representation for trial registration and study design
  • Retrieve Form for Data Capture (RFD) IHE Integration Profile (to capture data directly from electronic health records) and implementation of the HITSP Clinical Research Interoperability SpecificationSupport
• FDA needs for standards now:
  • New efficacy standards development
  • Refinement of SDTM (especially instructions for use) 

• Enable SHARE as a key goal of the CDISC Technical Roadmap

• Bind healthcare link with core CDISC standards development and support; integrate healthcare link roadmap with CDISC technical roadmap (same as 2009) and launch healthcare link opportunities

• Bring BRIDG to a global standard  

• Continue collaboration development and management on a global basis

• Identify new funding opportunities and manage operational tasks to the budget on a regular basis

As indicated previously, CDISC is working closely with the FDA representatives to address their current needs and in the coming weeks, we will be updating the overall CDISC Goals for 2010 to reflect those discussions. The 2010 Goals will be posted on the website thereafter.

CDISC Collaborations:

In 2010, CDISC will continue to represent your views and thoughts on a global basis in collaboration with a number of organizations. Over the next month, we will be developing a page for the website that will outline the organizations where your voice is being represented via CDISC and the value that is brought to you through your CDISC membership. These connections are vital to ensure that CDISC remains aligned with global developments, and they also ensure that the standards are being adopted as widely as possible. We’ll announce when the page goes live and you may be surprised at the number of organizations where you are represented.

CDISC Communications:

CDISC Communications continues to develop strategies to ensure all of you are receiving our messages; this year, in particular, we would like to hear more about your views on our digital strategy. In 2009, we launched the CDISC Primer to give everyone an overview of how the standards fit together, how to implement standards, the business case for standards and more. We launched a Twitter account, in order to microblog our activities and we recommend you follow this if you are not already doing so. Perhaps our major achievement last year was the launch of the new CDISC website, which has proved to be a popular move, judging by the number of hits we are getting and the great feedback we have received. The CDISC blog now resides on the CDISC website and has regular updates from our technical teams and communications on our activities.

So what next for CDISC Communications? In 2010 we plan to launch the CDISC journal, where we would like to encourage you to write articles or case studies about your implementation experiences. In the next few months, we will be asking you to submit articles for our first issue, which will be published to coincide with the CDISC Interchange in North America in October. We want all our community to share ideas and successes to support adoption and to help others just starting out on the standards road to implement successfully.

Finally, in 2010, please be sure you continue to support CDISC through membership. Whilst we keep our standards open and accessible to everyone, we need your membership to ensure that they continue to be supported and promoted on a global stage. We are grateful to those companies who have shown us continuous support and those individuals who give up valuable time and effort to ensure that we have an efficient and truly collaborative development process. 2010 will be as busy as ever and we look forward to you joining us on the journey.

AJ de Montjoie
CDISC Communications.

English Speaking User Group Face to Face Meeting

Implementing CDISC Standards from Protocol to P-Value

10 December 2009

Hosted by Medidata Solutions at Brunel University Conference Centre, Uxbridge

The day saw 53 delegates attend from across UK, Germany, Switzerland and Ireland.  There was variety amongst those in attendance in their working disciplines, from Data Managers, Statistical Programmers and Medical Writers.  There were also Software Vendors in attendance and also presenting.

In comfortable facilities, attendees were greeted by Donald Paterson (Amgen) who had co-ordinated the day’s programme, and outlined the agenda.

The first talk was presented by Mark LeBlanc (Eisai) and Michael Auld (Eisai), “Fast Tracking multiple studies using SDTM and ADaM”, which was an honest assessment of the practicalities involved in delivering multiple studies and the benefits and disadvantages of preparing submission-ready data at an early stage of development.  This encouraged a lot of questions from the floor which carried over into tea/coffee and into the afternoon.

Second to speak was Lauren Shinaberry (PRA International), who expanded the issues raised in the first talk, “A CRO perspective on implementation of SDTM across multiple sponsors”.  She talked about the difficulties in understanding the needs of the client, explaining that they could be grouped into 3 types: CDISC-naive, CDISC-expert, and those that were somewhere in between these two groups (the majority).  Also there were often subtle differences between clients’ interpretations of the CDISC standards – which could present confusion internally when repeating the same tasks to different clients.

Next was Darren Weston (Novartis) who presented, “CDISC – Mapping new pathways for Novartis”.  The challenges of organising data for a submission using Oracle Life Sciences Hub and a suite of existing SAS macros was detailed but also it was shown that understanding and clarifying what is required from regulatory authorities was the most revealing.

Following lunch was a live demonstration from our hosts Medidata - and the theme of the day, “From protocol to p-value: ODM along the critical path”, presented by Vaishali Patel (Medidata), Doug Bain (Medidata) and David Smith (SAS Institute).  They demonstrated an integrated end-to-end system incorporating Medidata Rave, Medidata Designer and SAS Data Integration Studio.  They showed that by entering protocol design information into the system (e.g. schedule of assessments, CDASH terminology) this could create metadata and help automate the setup for data capture and constraint checking, and that the heart of the exchange was data in the CDISC ODM format.  A strategy of integrating standards at all stages of the process was promoted, and the idea of multi-skilling across disciplines using the various software packages also emerged.

The final part of the day was an informal round-table “Birds of a Feather” session, in which delegates could discuss further the presentations with the authors.

Presentations can be found in the CDISC Portal under the English Speaking User Group.

At the time of the Intrachange in February we had already seen the annual release of the CDISC glossary with Version 7 being published both on the CDISC website and in Applied Clinical Trials. The month of March saw the publication of SDTM V1.2 and the associated Implementation Guide (IG) V3.1.2 and in the same month SEND V3.0 Draft A was released for use as part of the FDA/CDISC/Industry SEND pilot.

In April and May we saw a flurry of activity as the first version of the new Protocol standard V1.0 was released for public review, work started on support for Devices in SDTM and CDASH as work commenced on the HITSP EHR and Clinical Research interoperability specification.

The ADaM team released V2.1 of the standard and the first version V1.0 of the IG for public comment in the summer and as we approached the CDISC interchange in November BRIDG R3.0, ODM V1.3.1 and a substantial terminology package were all released for public comment. Around the same time the FDA announced the inclusion of SDTM V3.1.2 in their Study Data Specification and their acceptance of V3.1.2 submissions, while HITSP released the draft of IS/158, the  Clinical Research Interoperability Specification for public comment.

Within the last week the XML Technology team have released a guidance document on XML schema validation for define.xml to assist industry with issues in submitting define.xml to the FDA. This document was written in response to some issues uncovered during testing on SDTM data submissions being undertaken by CBER.

In parallel, CDISC has continued to work with Health Level 7 (HL7), ISO Technical Committee (TC) 215 and with Integrating the Healthcare Enterprise (IHE) on developing standards applicable to the clinical research domain and supporting the terminology needs of those projects. CDISC has also been starting to look at therapeutic area standards with partnerships in the areas of Cardiovascular, Diabetes, Parkinson & Alzheimer and Polycystic Kidney Disease.

In the next few weeks, we will see the CDASH V1.1 and the new CDASH User Guide (UG) V1.0 come out for public review and the formal release of the ADaM specification and the associated IG will take place before the end of the year.
And just to round off what is a pretty busy year the SHARE project has been proceeding with a significant amount of pilot work leading to a CDISC board decision to advance the project.

Looking back through the words, I see something like a dozen major items that CDISC will have posted for public comment or released at production status during 2009. This is an average of one a month. Given that the vast majority of the work within CDISC is undertaken by volunteers, this is a great achievement.

I want to finish by paying tribute to the volunteers, the team members and the team leads for their hours of dedication and effort. I would also like to thank their respective line managers and their organizations who allow them to be involved, who help CDISC by funding their time and their travel to such events as the Intrachange. Without them we could not deliver a product a month.

Dave Iberson-Hurst   
VP Technical Strategy

This year, many thanks to its wonderful volunteers, CDISC made significant progress in completing and ‘teeing up’ certain standards such that we will be going into 2010 with a complete suite of standards for biomedical research, from protocol representation through reporting and analysis.  This standards suite is augmented with interoperability specifications and integration profiles to enable the use of EHRs for research, while adhering to applicable regulations.   We are poised to benefit from the implementation of these transformational initiatives and products.

Specific accomplishments include (but are not limited to):

• The interoperability specification developed through HITSP, which identifies the CDISC IHE Retrieve Form for Data Capture (RFD) integration profile and CDISC CDASH to exchange a core set of research data from EHRs to clinical research systems
• The CDASH Implementation Guide and harmonization of CDASH elements with the NCI standard CRFs and CDEs
• BRIDG Release 3, which is targeted towards not only technology developers and modelers but also domain experts
• The Protocol Representation Model based on BRIDG, which includes the Trial Design Model (TDM) as in SDTM; the Clinical Trial Registration elements; Eligibility Criteria and other elements that are found in all protocols for research studies
• The application of the RFD to improve adverse event reporting (ASTER)
• Genomics augmentations for the LAB model (and coming for SDTM)
• And numerous terminology elements to enhance the interoperability and refinement of the CDISC standards

Additional progress was made in 2009 to pilot and determine how to build and implement SHARE to make the CDISC standards more accessible and identify terminology and value sets for the BRIDG model.  We have enjoyed strength through collaborations, in particular with the NCI and Mayo Clinic who enabled the SHARE pilot and those who contributed content for it (Mayo, MD Anderson, GSK, Lilly and Genzyme).

As this year draws to a close, we are excited to be working with CDER and CBER on a plan focusing on standards implementation, specifically to ‘tighten up’ SDTM and ADaM and to develop the efficacy data elements (which will also be in SHARE).

And, on the global front, we continue to grow, with 60 countries in our participant database and interest from Korea, India and China in solidifying CDISC Coordinating Committees and building Local Expert Groups.   We also continue to participate in the Joint Initiative Council (JIC) for International Harmonization (ISO, HL7, CEN, CDISC and IHTSDO) through which we will be balloting BRIDG in 2010.

On behalf of CDISC, its Board of Directors and Operations, we wish you all a joyous and peaceful holiday season and all the best for the coming New Year 2010.

Dr. Rebecca Kush
CDISC CEO and President

The conference was privileged to have several keynote speeches on the first day:  Dr. Frank Rockhold, GSK and Dr. Christopher Chute, Mayo Clinic College of Medicine. Key highlights from those opening speeches can be read on the CDISC Blog. The main thrust of Frank Rockhold’s presentation was to ensure that a global audience understood the imperative to implement the CDISC standards and how that message is conveyed to those outside of data management. As those of you who have tried to convey this message to senior managers will know, this is not always a simple task. We would recommend that you start by handing them a copy of the CDISC book: Introducing the CDISC Standards: New Efficiencies for Medical Research. Christopher Chute continued the broad theme of interoperability and also reinforced the message of working with healthcare to ensure that there is a close connection with research.  Both the keynotes emphasised a patient centred focus, something that is important to all of us. 

The CDISC Updates session has become an integral part of the Interchange and keeps our community abreast of the latest developments. Dr. Rebecca Kush began with her extensive roundup of the global activities that have taken place across 2009. You can read a summary of her presentation here on the Blog. She was followed by a summary from the CDISC Coordinating Committees in Europe, Japan and China who have all been busy with events and expounding the CDISC message. Concluding with the CDISC Team updates, it’s evident that CDISC is busier than ever working on the standards on behalf of its members.

Of course, our conference would not have been complete without the input from the FDA and this year we were honoured to have the new Principal Deputy Commissioner, Dr. Joshua Sharfstein, join us on the second day of the conference for his first meeting with the CDISC community. He was welcomed by Rebecca Kush and spent some time looking at the Healthcare Link demonstration in the lobby before taking to the podium to address an eager audience.  After an introduction by CDISC Board Chair, Dr. Edward Helton, he began with a lovely anecdote citing that he had been accepting every invitation to speak at conferences, including one to a cake manufacturers’ panel, at which point his assistant asked him politely to stop accepting everything that landed on his desk from Baltimore! He cancelled the cake speech, but he felt that CDISC was an opportunity too important to cancel and for that we are grateful.  

                                                                                                                            
If you have been reading our Blog, then you will be aware of the flurry of activity and discussion at the FDA Panel session.  Clearly, for most of the attendees this was one of the highlights of the event and you can read both Rebecca Kush’s views of the presentations by the panel and Dr. Sharfstein’s speech and Dave Iberson-Hurst’s impressions of that session on our Blog. We would welcome your comments and thoughts about the interesting discussions that took place. Feel free to add them to our blogs.

The sessions and the training revealed the growing implementation of the CDISC standards and greater understanding of the benefits of the standards. CDISC SHARE was presented for the first time at this interchange and interested audiences listened closely to the benefits of an industry wide shared metadata repository for health and research. The increased pressure on CDISC to develop efficacy (therapeutic area) standards will benefit considerably from CDISC SHARE and you can read more about SHARE on the website. The standard specific sessions were as busy as ever with presenters explaining their implementation successes and offering advice to audiences hungry for information. However, there is an ever-present need to encourage implementation of the standards and one of the focuses for this year has been to broaden our communication channels. With this in mind, Tweets were sent directly from the Interchange and Blogs were posted frequently on the website. If you haven’t already done so make sure you follow us on Twitter and subscribe to our RSS feed on the blog.

As usual our exhibitors were a fundamental part of the wonderful atmosphere at the conference, supplying expertise and, new this year, some of the vendors took part in the SDTM validation tools demonstration. These demonstrations are vital to support understanding of the Model and to ensure SDTM is implemented correctly. On Thursday, Landen Bain had the Healthcare Link participants demonstrating how information from EHRs can be successfully utilised for research purposes. The Retrieve Form for Data capture profile is part of the work that Landen has been involved with at IHE and this solution can be used now.

Of course, it goes without saying that the evening social event at the National Aquarium was a memorable experience for everyone. Starting with drinks and food at the Shark tank was wonderful, as everyone was treated to the sight of huge rays and some very impressive sharks swimming beneath them.  Attendees chatted informally as they wandered through the various displays and eventually found themselves at the spectacular jellyfish exhibition, where they were also greeted with some rather delicious cakes and pastries. It was a truly unique event and we thank the Aquarium for our private viewing. I am assured that no-one went missing and there were no particularly fat sharks after everyone had left!

Once again, CDISC would like to thank all those who contributed to the success of this event particularly the CDISC Advisory Board who developed an excellent program, the many speakers who had prepared excellent presentations, the exhibitors and of course all the attendees who bring so much to CDISC, both as volunteers and as part of our collaborative community.  We look forward to you joining us in 2010!

Interchange Europe, Lancaster Hotel, London, United Kingdom
26 – 30 April 2010 (Call for abstracts now open)

Interchange Japan, Tokyo, 27 – 30 July 2010

AJ de Montjoie

Over the last decade, the Clinical Data Interchange Standards Consortium (CDISC) has acted as the catalyst for productive collaboration to develop and encourage adoption of standards through a consensus-based approach. The collective efforts of more than 250 CDISC member organizations, representing biopharmaceutical companies, academic research, CROs, government, service and technology provider organizations, has enabled robust standards development.

The result of this collaboration--CDISC Standards are named in regulatory guidance as the recommended standard for submission of electronic safety and efficacy data to the US Food and Drug Administration and in Health Information Technology Standards Panel (HITSP) interoperability specifications for use of EHRs for medical research.

CDISC members enjoy these benefits and more...

• Receive significant discounts on CDISC events, training and publications
• Stay informed and make a difference: provide your input and directly impact the standards development process, while connecting with peers and keeping abreast of industry trends and best practices 
• Leadership through participation on the CDISC Advisory Board 
• Access to CDISC Members (Only) Area on www.cdisc.org for information on implementation best practices, tips and tools 
• Ensure, through your financial support, that the standard data needs of medical research are incorporated in the fabric of global healthcare infrastructure reform

Join the collaborative efforts of 250 CDISC members!

To become a CDISC member complete the on-line application.  For further information on membership fees and benefits, or questions contact Tanyss Mason by email or call:  +1 919 419 7100. 

As members and/or supporters of the Clinical Data Interchange Standards Consortium (CDISC) Global Expert Group, we wish to encourage the advocacy and adoption, along with continued collaborative development, harmonization and support of the CDISC global clinical data standards that facilitate the clinical research process while integrating it into the healthcare arena...

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