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

被引：10

作者：

Reed, Shelby D. ^{[1
]}

Anstrom, Kevin J. ^{[1
]}

Seils, Damon M. ^{[1
]}

Califf, Robert M. ^{[2
]}

Schulman, Kevin A. ^{[3
]}

机构：

[1] Duke Univ, Sch Med, Duke Clin Res Inst, Ctr Clin Genet & Genet Econ, Durham, NC 27706 USA

[2] Duke Translat Med Inst, Durham, NC 27706 USA

[3] Dukes Fuqua Sch Business, Durham, NC 27706 USA

来源：

HEALTH AFFAIRS | 2008年 / 27卷 / 05期

关键词：

D O I：

10.1377/hlthaff.27.5.w360

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

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)]

引用

页码：W360 / W370

页数：11