Report Examines Cost-Effectiveness of Larger Clinical Trials To Prevent Postapproval Adverse Events

"Use of Larger Versus Smaller Drug-Safety Databases Before Regulatory Approval: The Trade-Offs," Health Affairs: In the Web exclusive, Shelby Reed, an associate professor of medicine at the Duke University Clinical Research Institute, and colleagues evaluate the potential benefits and costs of requiring larger sample sizes in preapproval clinical trials for new prescription drugs. The researchers used a hypothetical model to estimate the expected incremental number of adverse drug events that could be avoided after a drug receives FDA approval. The study finds that requiring larger preapproval clinical trials could be a cost-effective way to reduce adverse drug events. A Web exclusive perspective responding to the study also is available online (Health Affairs release, 8/5).