Bayesian Adaptive Trials for Drug Safety

The U.S. Food and Drug Administration (FDA) has increased their focus on premarket conrmations of drug safety. Recent drug withdrawals include rofecoxib, valdecoxib, fen-phen, and tegaserod all for cardiovascular (CV) safety concerns that became apparent after these drugs were approved [1-3]. Other drugs such as rosiglitazone are prescribed with tighter restrictions after they were found to produce a higher CV risk [4]. These removals have led to requirements for evidence of drug safety for many new drug approvals. For instance, any diabetes drug must, in addition to efcacy, demonstrate that it is heart safe [5].