Society report encourages preliminary sex analysis of clinical trial data

Washington, DC Noting that women should be appropriately included in clinical research, the Society for Women's Health Research today issued a report that encourages the application of sex analysis early in the clinical research process to more accurately gauge sex-based differences.

Published online Tuesday by Medscape, the report, Understanding the Biology of Sex and Gender Differences: Using Subgroup Analysis and Statistical Design to Detect Sex Differences in Clinical Trials, addresses the importance of statistical design and subgroup analysis to ensure that drug trials are able to detect any sex differences in response to an investigational drug or device.

"This report addresses the importance of detecting sex differences in early-phase clinical trials and translating those findings into appropriate dosing regimens. We've made great strides to include women in clinical trials, but now we must focus on the design of these trials to most accurately and efficiently detect differences in men and women," said Sherry A. Marts, PhD, scientific director of the Society for Women's Health Research and co-author of the survey.

The Society for Women's Health Research report focuses on a July 2001 Scientific Advisory Meeting and workshop that featured a variety of clinical researchers who spoke on methodologies available for appropriate sex analysis of clinical trial data.

Highlighting the importance of timely subgroup analysis for obtaining accurate and cost-effective results, Carl Peck, MD, Professor of Pharmacology and Medicine at the Center for Drug Development Science at Georgetown University, spoke on pharmocokinetic and pharmacodynamic analysis and the importance of conducting such analyses within the first phase of a clinical trial.

Peck referred to the lipid protease inhibitor tirilazad as an example of how untimely subgroup analysis can lead to a drug's failure in the approval process. In animal models of stroke, tiri

Contact: Amy Hoskins
Society for Women's Health Research

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