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

Main Category: Clinical Trials / Drug Trials
Article Date: 07 Aug 2008 - 10:00 PST

email to a friend   printer friendly   view / write opinions   rate article

"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).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.