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Medical News and Perspectives
June 27, 2012

FDA and Pharma Seek Better Ways to Assess Drug Safety, Efficacy in Clinical Trials

JAMA. 2012;307(24):2576-2577. doi:10.1001/jama.2012.6684

Pharmaceutical manufacturers and the US Food and Drug Administration (FDA) agree that finding ways to improve the process of drug testing to make it faster while still ensuring medication safety and efficacy is a worthy goal. Some researchers are suggesting that changes in how trial data are assessed may help streamline this process.

The issue for these researchers is a type of analysis called “intention to treat,” which is meant to eliminate the potential for biased results. This method for studying the results of a randomized clinical trial, in which patients are randomly assigned to groups that either receive an intervention or function as a control, is a preferred analytic method for the FDA and scientists. An intention-to-treat design calls for analyzing results of all participants in the groups to which they were randomized, even those who drop out for a variety of reasons or do not adhere to the proper medication schedule. Both actions can skew trial results and can often end up resulting in underestimating the safety or the efficacy of a tested medication.

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