DIA/FDA Statistics Forum 2014

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.