Why Products Fail in Phase III
Executive Summary
Half of the small-molecule drugs that fail pivotal trials can't prove better efficacy than placebos. The most important predictor of failure: a drug with a novel mechanism of action. But for the most part, companies are pursuing a one-size-fits-all development strategy, using the same methods for developing drugs that modulate novel and precedented targets. Companies need to better differentiate their development strategies based on risk.