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Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database

Basic Details
Date Posted
Status
Complete
Description

FDA, Mini-Sentinel, and CTTI (the Clinical Trials Transformation Initiative) assessed the potential for conducting randomized trials in the Mini-Sentinel environment. This report details the Mini-Sentinel Data Partners’ experience, interest, and capability in partnering in the conduct of randomized trials. Topics addressed include: protocol development; identification of potential trial participants, engagement of providers, direct-to-patient engagement, and the role of policy interventions to effect change. The report includes use cases and an analysis of privacy and regulatory issues relevant to Mini-Sentinel data partners’ participation in clinical trials.