Simulation Of Clinical Scenarios Important To Support Adaptive Trial Designs
FDA has approved one drug supported by an adaptive design, but the trial did not save money or time, FDA statistician tells regulatory professionals.
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A Drug Information Association working group survey found 477 studies between Jan. 1, 2008 and Sept. 1, 2011 utilized some type of adaptive design.
FDA draft guidance explains how adaptive trial designs can help implement enrichment strategies when there is uncertainty about a predictive marker’s power.
Exelixis' Lead-In Trial Design Evaluates Cabozantinib Disease Activity Against Multiple Cancers At 12 Weeks
Novel adaptive randomized discontinuation design tested cabozantinib in nine tumor types, isolated best opportunities faster than traditional randomization.