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"Use of Larger Versus Smaller Drug-Safety Databases Before Regulatory Approval: The Trade-Offs," Health Affairs: In the Web sole, 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 victimised 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-efficient way to reduce contrary drug events. A Web exclusive perspective responding to the study also is available on-line (Health Affairs release, 8/5).
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