Keys to Mitigating Risk in Adaptive Trials

Posted: 08/29/16

Phase III trials are the big, expensive ones that come right before a drug is submitted to a regulatory agency for approval. Phase III trials cost about $20 million, so you can see why the fact that about 50% of them fail is a big problem. Sy Pretorius, Chief Scientific Officer of PAREXEL, a leading international pharmaceutical consulting firm, believes that high rate of failure is due to traditional 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 trial terminations), thereby saving companies a whole lot of time and money. We helped Pretorius publish his article about how to run adaptive trials (which are more complex than traditional ones) safely and effectively in Life Science Leader, here.