Combining Adaptive Designs With Enrichment Strategies
FDA draft guidance explains how adaptive trial designs can help implement enrichment strategies when there is uncertainty about a predictive marker’s power.
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FDA has approved one drug supported by an adaptive design, but the trial did not save money or time, FDA statistician tells regulatory professionals.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.