Health Affairs

Health Affairs, 27, no. 5 (2008): w360-w370 (Published online 5 August 2008) doi: 10.1377/hlthaff.27.5.w360 © 2008 by Project HOPE	New Online   Getting Health Reform Done   After the State of the Union   Incremental Reform   E-Health in Developing World   Most-Read Articles in 2009

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Use Of Larger Versus Smaller Drug-Safety Databases Before Regulatory Approval: The Trade-Offs

Shelby D. Reed, Kevin J. Anstrom, Damon M. Seils, Robert M. Califf and Kevin A. Schulman

Although efforts to revamp the drug-safety system have been directed at strengthening postmarketing surveillance, strategies for the preapproval stage may be useful. One strategy would be to require larger sample sizes in preapproval safety databases. To evaluate the potential benefits and costs of this approach, we developed a hypothetical model to estimate the expected incremental number of adverse drug events that could be avoided in a postapproval population. We found that the potential to limit adverse events can be an important consideration in sample-size determinations for preapproval trials. Requiring larger preapproval databases could be a cost-effective means of reducing adverse events in postapproval populations.

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