Newsroom

Tucson, AZ , Austin, TX - Critical Path Institute’s (C-Path) Polycystic Kidney Disease Outcomes Consortium (PKDOC) (http://www.c-path.org/pkd.cfm) , the Clinical Data Interchange Standards Consortium (CDISC), and the PKD Foundation announced today the launch of version 1.0 of the Polycystic Kidney Disease (PKD) Therapeutic Area User Guide, a clinical data standard that provides guidance on the implementation of the CDISC Study Data Tabulation Model (SDTM) to represent PKD data in regulatory submissions. This user guide, when used with the SDTM, is intended to guide the organization, structure, and format of standard PKD clinical trial tabulation datasets submitted to a regulatory authority such as the US Food and Drug Administration (FDA). This clinical data standard has also been used to aggregate data from several PKD patient registries and observational studies to analyze disease progression in PKD. “The development of the PKD Data Standard represents a major step forward in the development of therapies for PKD,” said Ron Perrone, Professor of Medicine at Tufts University School of Medicine, and Director of the Tufts Center for PKD and Co-Director of the PKDOC. “This kidney disease specific standard will shorten the time for initiation of clinical trials and will facilitate data interchange with regulatory agencies, thereby helping to speed the pace of therapeutics development and potentially improving outcomes for patients.” Perrone is also a member of the PKD Foundation’s Scientific Advisory Committee. The PKD Foundation provided funding for the PKDOC and the CDISC standards development effort.

CDISC standards are freely available via the CDISC website. To learn more about the PKD Therapeutic Area User Guide and to download the associated standards package, please visit the CDISC website: http://www.cdisc.org/therapeutic.

“This release marks another major milestone in the development of a set of global, platform-independent therapeutic area data standards. The way we were able to work with academic clinicians from Emory University, the Mayo Clinic, Tufts University and the University of Colorado-Denver to develop and reach consensus on PKD data elements was ground breaking for us.

Austin, TX – 11 March 2013 – The Clinical Data Interchange Standards Consortium (CDISC) is proud to announce the 10th CDISC Europe Interchange, to be held 22-26 April 2013 near Frankfurt, Germany. The conference, planned by the CDISC European Coordinating Committee (E3C), will include an all-star list of speakers.

The 2013 Europe Interchange Keynote will be delivered by Dr. Michel Goldman, head of the Innovative Medicines Initiative (IMI). Frank Petavy of the European Medicines Agency (EMA) will give a presentation on the Clinical Trial Transparency Initiative, and Dr. Charles Cooper of the U.S. Food and Drug Administration (FDA) will present on Data Standards in the FDA – Challenges and Processes. Additional Interchange speakers will represent TransCelerate Biopharma and CDISC members and standards adopters. “We are extremely pleased that experts will be presenting on behalf of FDA, EMA and IMI during this 10th CDISC European Interchange, which will be held in Bad Nauheim (near Frankfurt), where Elvis Presley spent two years of his life,” said Peter van Reusel, who chairs the E3C. “We can look forward to a very special evening event, for which our European Interchanges have become renowned.”

Austin, TX – 7 March 2013 - The Clinical Data Interchange Standards Consortium (CDISC) organized and hosted a meeting in Austin, TX to launch the Essential Standards to Enable Learning (ESTEL) initiative of the Learning Health Community (LHC). The CDISC-led ESTEL initiative is the first of several that have grown out of the May 2012 Learning Health System (LHS) Summit, sponsored by the Joseph H. Kanter Family Foundation (KFF), which convened a critical mass of key stakeholders representing over 80 organizations across the healthcare spectrum and achieved multi-stakeholder consensus on a set of ten LHS Core Values that will underpin a national-scale LHS. Such consensus has given rise to the self-organizing (and ever-growing) Learning Health Community bonded together by a shared belief in the Core Values and a common drive to work collaboratively to transform healthcare and health by realizing an LHS. A key goal of a Learning Health System (LHS) is to significantly shorten the time by which clinical research results inform clinical care decisions to improve the lives of patients.

Tucson, AZ and Austin, TX – January 29, 2013 - The Coalition for Accelerating Standards and Therapies (CFAST), a joint effort between the Clinical Data Interchange Standards Consortium (CDISC) and Critical Path Institute (C-Path), in collaboration with the National Institute of Neurological Disorders and Stroke (NINDS), announces the availability of an important new resource in the fight against Parkinson’s disease (PD). Parkinson’s disease is a debilitating condition that affects an estimated 1,000,000 in the U.S. and as many as 7,000,000 people worldwide.

This new resource, the Parkinson’s disease CDISC Therapeutic Area Data Standard, provides a defined and consistent way to store, and submit clinical trial data for PD. The new standard will help researchers combine and evaluate data from multiple studies, streamline the efficiencies of new clinical trials, and aid the evaluation of new drugs and treatments for PD.

Austin, TX – 2 January 2013 – CDISC is pleased to announce that five highly qualified individuals will add invaluable expertise to the CDISC Board of Directors (BoD) for a three-year term beginning this month (2013—2016). Dr. Carolyn Compton, Michael Glickman, Dr. Douglas Peddicord, Stephen Pyke, and John Speakman each contribute unique skillsets to the BoD that will greatly assist CDISC as it moves forward with its Strategic Goals in 2013. Sincere appreciation goes to Dr. Steven Hirschfeld and Robert Goodwin, who completed their CDISC Board service in December 2012 and to Wayne Kubick who has become the Chief Technology Officer for CDISC.

Carolyn Compton, M.D. and Ph.D., is the current President and CEO of the Critical Path Institute (C-Path), which is partnered with CDISC through the Coalition For Accelerating Standards and Therapies (CFAST) and other initiatives such as the Coalition Against Major Diseases (CAMD) and the Critical Path to TB Drug Regimens (CPTR) through which the CDISC Alzheimer’s Disease and Tuberculosis standards were developed, respectively. Dr. Compton’s professional history is impressive, with 15 years spent as the Director of Gastrointestinal Pathology at the Massachusetts General Hospital, as a Professor of Pathology at Harvard Medical School and the Chair of Pathology and Pathologist-in-Chief at McGill University Health Center. Before taking on her current role at C-Path, Dr. Compton was Director of the Office of Biorepositories and Biospecimen Research and the Executive Director of the Cancer Human Biobank Project at the National Cancer Institute, where she was critical in implementing a number of key, groundbreaking research informatics solutions that were based on data standards.

Austin, TX – 5 December 2012 – The Clinical Data Interchange Standards Consortium (CDISC) is proud to announce the launch of the inaugural CDISC Asia-Pacific Interchange to be held 18-22 February 2013 in Singapore. Singapore was chosen for its central location in this region, the epicenter of some of the most booming economies in the world.

“We are excited to offer this Interchange in Singapore, an event which essentially brings CDISC to the doorstep of our many loyal members and supporters throughout the Asia-Pacific region. This Interchange will offer companies in Asia-Pacific the rare opportunity to collaborate with and gain information about best practices in clinical data standards implementation from their peers in the region,” said Paula Brown Stafford, President of Clinical Development at Quintiles and CDISC Board Chair.

Austin, TX – 6 November 2012 – The CDISC International Interchange in Baltimore, Maryland, held 22-26 October 2012, was the formal launch of the Coalition for Accelerating Standards and Therapies (CFAST). It also marked the 10th anniversary of these CDISC Interchanges. In 2003 at the first North American CDISC Interchange, Dr. Mark McClellan, then FDA Commissioner, gave the keynote speech, stating “I think that CDISC will be a big part of moving FDA onto an electronic information architecture where we can realize all of these opportunities [benefits of technology]. I think this will have a profound and positive impact on our drug review process, allowing us to design trials that can be less expensive and still tell us more about the risks and benefits of a new medical product. And I think that the most significant and perhaps enduring legacy to your efforts could be the very immediate and significant impact it has on improving the lives of patients.”

Formal Launch of CFAST - collaboration between C-Path and CDISC

Austin, TX - 12 September 2012 - The Clinical Data Interchange Standards Consortium (CDISC) and Critical Path Institute (C-Path) announce the launch of the Coalition For Accelerating Standards and Therapies (CFAST), a follow-up to the partnership agreement signed earlier this year. The official launch of CFAST will take place at the CDISC 2012 International Interchange in Baltimore, Maryland (24-26 October 2012).

CFAST is an initiative to accelerate clinical research and medical product development by facilitating the creation and maintenance of data standards, tools, and methods for conducting research in therapeutic areas important to public health. To date, CDISC has either released draft or provisional standards packages covering five different disease areas: Parkinson’s, Alzheimer’s, Tuberculosis, Virology and Pain. Upcoming releases will include therapeutic area standards packages for Polycystic Kidney Disease, Cardiovascular Disease and Schizophrenia.

Tucson, AZ - 10 September 2012 – Critical Path Institute and CDISC (Clinical Data Interchange Standards Consortium) announce the availability of a breakthrough tool to help combat tuberculosis (TB)—a persistent disease resulting in 1.7 million deaths globally each year.

This new tool—a standardized way to report research data—is critical for advancing new TB drug regimens. For the first time, researchers are able to combine and evaluate data from multiple studies using a common approach. This will help accelerate the development of new TB drugs by enhancing the design of clinical trials and the evaluation of new drugs. The TB data standards will also assist the regulatory review process for new drug development tools, such as clinical trial simulation models and methods to evaluate treatment endpoints.

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.”

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.