Meet C3TI, FDA’s new clinical trial innovation hub


On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). The announcement includes a scope of projects for the initiative, with a particular focus on pragmatic trial elements, Bayesian analyses and selective safety data collection methods.

The traditional model of clinical trials is well-established, and in particular the two-armed, double-blind placebo-controlled randomized control trial, run out of centralized clinical trial sites.

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