Health Affairs

Health Affairs, doi: 10.1377/hlthaff.27.5.w360 (Published online August 5, 2008) © 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 ¹, Kevin J. Anstrom ², Damon M. Seils ³, Robert M. Califf ⁴, Kevin A. Schulman ^5*

¹ Shelby Reed is an associate professor in medicine at the Duke University School of Medicine in Durham, North Carolina.
² Kevin Anstrom is an assistant professor of biostatistics and bioinformatics at the Duke University School of Medicine in Durham, North Carolina.
³ Damon Seils is a senior research analyst at the Center for Clinical and Genetic Economics, Duke Clinical Research Institute (DCRI), Duke University School of Medicine.
⁴ Robert Califf is a professor of medicine and the Donald F. Fortin, MD, Professor of Cardiology at the Duke University School of Medicine, the director of the Duke Translational Medicine Institute, and vice chancellor for clinical research, Duke University.
⁵ Kevin Schulman is a professor of medicine at the Duke University School of Medicine, a professor of business administration at Duke's Fuqua School of Business, the director of the Center for Clinical and Genetic Economics, and an associate director of the DCRI.

^*Corresponding author.

Abstract

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. [Health Affairs 27, no. 5 (2008): w360-w370 (published online 5 August 2008; 10.1377/hlthaff.27.5.w360)]

Key Words: Consumer Issues, Elderly, Consumer Issues, Legal/Regulatory Issues, Pharmaceuticals, Research And Technology

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