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Session 4 - Clinical Trials Data: Using Standards and Establishing Transparency
Session Chair(s)
Ivan S. F. Chan, PhD
Executive Director, Biostatistics, Late Development Statistics
Merck Research Laboratories, United States
Steve Wilson, PhD
Senior Staff Fellow, OB, OTS, CDER
FDA, United States
Statisticians and clinicians who develop and review medical products depend heavily on high quality clinical trials data to provide evidence for approval and labeling claims. This is a “Data Session” – designed to bring us all up-to-date on the progress of two important initiatives associated with these clinical trials data. 1) PDUFA V Goals point towards the development of CDISC data standards for the submission of these data to FDA/CDER. This session will provide an FDA review perspective on the progress made with the development and application of these standards for data collection, data management, statistical programming, analysis, reporting and review (from protocol to decision). 2) It has also become very apparent that there is growing interest in making these clinical trials data more available to the public, more “transparent.” The European Medicines Agency has announced that it will proactively publish clinical-trial data and enable access to full data sets by interested parties.” Companies are thinking hard and dedicating staff to figure out what this will look like. What are the concerns, complexities and processes? Data privacy and “stewardship” are two major issues. In this session we will learn more about what companies are thinking and doing to assure the secure access and the privacy of “shared” clinical trials data – to become responsible “stewards” for the secondary use of these important/expensive/valuable data.
Speaker(s)
Data Transparency: Protecting the Patient and the Sponsor
Jonathan S. Hartzel, PhD
Merck and Co., Inc. , United States
Biometrician
FDASIA/PDUFA V, Data Standards and Statistical Review: An Update
Benjamin Peter Behrang Vali, MS
FDA, United States
Regulatory Affairs Officer and Project Manager, DGIEP, OND, CDER
Increased Clinical Data Transparency: Building Trust and Advancing Public Health
Jesse Berlin, DrSc
Johnson & Johnson, United States
Senior Vice President, Epidemiology
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