Use of Regulatory Databases as Exemplars for Improving Randomized Clinical Trial Efficiency: Can the model be extended?

Chairs: Tiffany Farchione, MD;  Heddie Martynowicz, DM, MS

This session will examine approaches for using data from existing regulatory databases to improve the methodology for future CNS clinical trials and highlight work by regulatory colleagues from the Food and Drug Administration (FDA), and the European Medicines Agency (EMA) in utilizing their databases to answer regulatory questions.  Strengths and limitations of this work will be discussed with an eye to building on this work and expanding it to new areas.  Industry perspectives and potential opportunities for industry/regulatory agency collaborations to answer questions from their large data sets will also be presented. The session will conclude with a panel discussion where representatives from FDA, EMA, academia, and industry will discuss limitations, gaps, and future opportunities for using existing databases to improve the methodology for CNS clinical trials.