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Austin, TX – 18 April 2012 – The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce today at the CDISC European Interchange Conference in Stockholm, Sweden, the release of the first iteration of a Protocol Representation “Toolkit” for clinical research. The purpose is to make it easy for authors of the research plan or protocol to reap the benefits of the Protocol Representation Model (PRM), which has been developed over the past decade by global clinical research experts from academia, industry and government. Using such a model can save time and resources for research studies by enabling electronic re-use of protocol information for other purposes such as clinical trial registration, study tracking, regulatory information and study reports. The current release of the “Toolkit” includes a standard Study Outline Template in MS Word format, a standard list of Study Outline Concepts, and a complete mapping of the Study Outline Concepts to both the Biomedical Research Integrated Domain Group (BRIDG) model and the CDISC Study Data Tabulation Model (SDTM) Trial Summary (TS) Domain.

"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 Clinical Data Interchange Standards Consortium (CDISC) announced a public review and comment period for the new CDISC Device Standards and encouragement for device companies to be involved in CDISC activities. This marks the first development by CDISC of standards for device trials. The draft document contains seven proposed new Study Data Tabulation Model (SDTM) domains that are designed to capture basic information about medical devices for the purpose of streamlining product reviews by the Food and Drug Administration (FDA). These domains have been modeled on and work in concert with existing SDTM constructs.

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.”

Austin, TX – 23 March 2012 – Clinical Data Interchange Standards Consortium (CDISC) standards were at the core of two recent Global R&D IS Innovation Awards at Genzyme/Sanofi. Out of 208 dossiers submitted, GetSMART (which involved implementation of a number of CDISC standards) won in the ‘Internal Business Value’ category. RegistryNXT! (which is based on the collaborative BRIDG model) won in the ‘Value to Patients’ category. Criteria for evaluation of the dossiers included: Competitiveness and Value Creation, Opportunities, Breakthrough and Creativity, Simple and Clever, Innovation Behavior, Collaboration with Different Entities/Breaking Silos and a bonus criterion of Sustainability/Green Value.

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.”

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.

First in a series of therapeutic area data standards

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.

Austin, TX – 16 March 2012 –The Clinical Data Interchange Standards Consortium (CDISC) and the Pharmaceutical Users Software Exchange (PhUSE) are pleased to announce an agreement to work cooperatively to facilitate the adoption and implementation of CDISC standards to streamline clinical research. Many CDISC staff and volunteers will be actively participating in a collaborative meeting, organized by PhUSE on behalf of FDA, to be held in Silver Spring, MD on 19-20 March 2012. This FDA Annual Computational Science Symposium is entitled “Update on Standards, Tools, and Process Initiatives across Regulatory Review and Collaboration with Key Working Groups to Improve the Product Lifecycle.”

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.

Austin, TX – 14 September 2011 – “Standards for Patients” is the theme of the coming CDISC International Interchange, which will take place in Baltimore on 10-14 October 2011. This theme will also be the focus of a set of Colloquia to continue development of standards to support the collection of clinical research efficacy data and to facilitate regulatory reviews of clinical research data in eSubmissions for approval of potential new therapeutic products.

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.

Austin, TX – 20 December 2011 – On Monday, 5 December, CDISC was notified by the U.S. Internal Revenue Service (IRS) that it is approved as a 501(c)(3) organization, recognizing CDISC as a charitable organization retroactive to May 2011. While CDISC has been a 501(c) tax-exempt, non-profit organization since February 2000, this new status offers added benefits to assist CDISC in achieving its mission, vision and goals.

Just one of the benefits of this new status is the ability to receive tax-deductible contributions from individual and corporate donors. This will assist in promoting CDISC’s message to a broader audience, enhancing CDISC’s capacity to locate funds through diverse means. CDISC has always been exempt from paying federal corporate income tax, but will now no longer be required to pay sales tax; this will allow for these funds to be put toward CDISC’s strategic goals, which include the development of global disease-specific research standards to benefit patients around the world. Follow the link.

Austin, TX – 18 January 2012 – CDISC ushers in the New Year with changes to its leadership.  The addition of three highly qualified individuals to its board of directors will bring invaluable expertise to the CDISC organization for the term 2012 - 2015.  Returning to the Board are Dr. C. David Hardison, and Dr. Pierre-Yves Lastic, joined by new board member Mr. Robert Goodwin. Each brings a unique skillset to the BoD to help guide CDISC as it moves forward with its goals and initiatives in 2012. Sincere appreciation goes to Dr. Charles Mead and Mr. Shawn Wang, who have now completed their terms on the CDISC Board of Directors.

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.

Purpose  Physicians in the United States report fewer than 1% of adverse drug events (ADEs) to the Food and Drug Administration (FDA), but frequently document ADEs within electronic health records (EHRs). We developed and implemented a generalizable, scalable EHR-based system to automatically send electronic ADE reports to the FDA in real-time.

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.

In January, 2010, the CDISC Protocol Representation Group published the final Protocol Representation Model Version 1.0.  The PRM has been described in detail in a number or articles, blogs and in its own documentation.  The intent of this article is to provide simple, basic answers to questions that have arisen recently about the PRM ...

Austin, TX – 12 October 2010 – The CDISC North American Interchange is to be held in Baltimore, MD, 1 – 5 November 2010. The CDISC Board of Directors and Dr. Rebecca Kush, President & CEO are pleased to announce three exceptional keynote speakers to introduce this year’s event: Dr. Doug Fridsma, acting director of the Office of Interoperability and Standards in the Office of the National Coordinator for Health Information Technology; Dr. Theresa M. Mullin, Ph.D., Director, Office of Planning and Informatics, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA) and Dr. Raymond L. Woosley, Founder and Chief Executive Officer of the Critical Path Institute (C-Path).

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 ...

The CDISC English Speaking User Group (www.esug.org.uk) is fast approaching its third birthday and, as time passes, we firmly believe that we are not only making significant progress in promoting the work and deliverables of CDISC amongst the English speaking world, but also developing the tools and structures which will help us to continue to do this in the months and years ahead.

Austin, TX – 28 October 2010 – CDISC standards now cover the entire biomedical research process, from protocol representation through analysis and reporting. Over the last two years it has become clear that in order to increase the delivery of standards updates and meet the needs of industry and regulatory bodies, CDISC needed a different model to augment its current processes. The CDISC Shared Health And Clinical Research Electronic Library (CDISC SHARE) is envisioned as a global, accessible, electronic library, which through advanced technology, enables precise and standardized data element definitions that can be used within applications and across studies to improve biomedical research and its link with healthcare.  This new initiative seeks to develop multi-dimensional, machine-readable clinical study metadata that is based on ISO data standards and the BRIDG model.

As always, CDISC begins the year with a flurry of activity (do keep an eye on the website for regular updates and news on the standards).  In addition to the CDISC standards themselves, the CDISC Board and Operations Staff also spent the last quarter of the year reviewing the CDISC Strategy and making appropriate changes (see the new CDISC Strategy 2010)...

As Dr. Frank Rockhold assumes the position of Chair, CDISC Board of Directors, this month, CDISC would like to formally congratulate Paula Brown-Stafford on being voted as the new Chair Elect of the CDISC Board.  Paula has more than 20 years experience of working in the Pharmaceutical and CRO industry. She has worked closely with the CDISC standards and has ensured that Quintiles has devoted time and energy to their implementation within the organization ...

The CDISC-AdvaMed Device Team has covered a lot of ground since the last CDISC newsletter update.  As many of you are aware, this project seeks to develop in parallel the CDASH data collection fields, the SDTM submission variables and the associated metadata for basic device clinical studies...

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 ...

CDISC, the Clinical Data Interchange Standards Consortium is an international standards development organization whose 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”.

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.