Industry Encouraged To Spread Its Wings In Learn Phase of Adaptive Trials

摘要

While FDA is granting industry a great deal of leeway in designing early, learn-phase adaptive trial models, the agency is suggesting that emphasis be placed on dose response and exposure risk, FDA officials indicated at a recent Pharmaceutical Research & Manufacturers of America workshop."The two major causes of delayed approval and nonapproval of Phase III studies is poor dose selection in early studies and Phase III designs [that] don't utilize information from early phase studies," FDA Statistician Stella Machado said.