Developing Approaches to Conducting Randomized Trials Using Mini-Sentinel: Webinar and White Paper


A recent webinar (see recording) covered a collaborative effort of the Clinical Trials Transformation Initiative (CTTI) and the FDA Mini-Sentinel project in which investigators are exploring the possibility of using the Mini-Sentinel distributed database infrastructure to conduct randomized, multicenter clinical trials. Speakers Richard Platt, MD, MS, of Harvard Pilgrim Health Care Institute, and Patrick Archdeacon, MD, of the FDA, summarized the work and discussed next steps that will continue to advance the project.

A white paper published earlier this year, Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database, describes the results of the investigator analysis in greater detail. The white paper is the product of the CTTI Uses of Electronic Data project.