Keys to Mitigating Risk in Adaptive Trials

Posted: 08/29/16

Phase III trials, which come right before a drug is submitted to a regulatory agency for approval, cost about $20 million. The fact that about 50% of them fail is a big problem. Sy Pretorius, Chief Scientific Officer of PAREXEL, a leading global pharmaceutical consulting firm, believes this high rate of failure is due to traditionally rigid trial designs. He argues that adaptive designs that enable trials to change as new data is collected can reduce failures (or lead to faster terminations). We helped Pretorius publish his article, "Three Keys to Mitigating Risk in Adapative Trials," in Life Science Leader.