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Executive Summary--Gender Studies in Product Development

On November 6 and 7, 1995, the Food and Drug Administration’s Office of Women’s Health, in collaboration with the FDA’s Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health, convened a public workshop entitled "Gender Studies in Product Development: Scientific Issues and Approaches." The meeting was designed to explore the science involved with assessing gender effects during the development of medical products, including drugs, biologics, and medical devices, and to identify significant areas for further research and policy development.

The Gender Workshop was organized around three broad topics that affect the evaluation of medical products used by women: 1) pharmacokinetics and pharmacodynamics; 2) hormonal influences; and 3) study design and analysis.

Four critical questions were explored:

  1. How can drug trials be designed to detect clinically relevant differences between men and women? Can better pharmacokinetic (PK) and pharmacodynamic (PD) data help?
  2. When during the drug development process does it become possible to identify gender effects?
  3. What factors are important for determining whether an observed difference may be clinically significant enough to warrant further study?
  4. Under what circumstances are dosing regimens apt to be different for men and women and how can this be determined?

Based on the workshop conclusions and recommendations, and coupled with the 1993 gender guideline, which emphasizes enrolling adequate numbers of women in clinical trials and conducting appropriate analyses, FDA believes that a reasonably coherent picture is emerging of how and when to assess gender effects during the drug development process. Methodologies available to assess gender and other population subset effects include: 1) in-vitro studies in human and non-human tissue and in-vivo studies in non-human species; 2) early phase exploratory clinical studies using pharmacokinetic and pharmacodynamic approaches, coupled with a mechanistic understanding of drug action, if available; and 3) late confirmatory studies in humans. It is the FDA’s judgment that sponsors can and should use early studies to identify the presence or absence of important gender differences and to adjust later trials to evaluate the clinical importance of these differences. Late phase studies may signal by-gender safety and efficacy differentials via post-hoc subset analyses.

This Executive Summary captures highlights of the two-day workshop and places the issue of identifying gender-related drug effects in an historical context. The discussions and recommendations of the three panels are summarized here; detailed excerpts from the speaker presentations are available in a separate document. This document can be obtained by filing a written freedom of information request to Food and Drug Administration, Freedom of Information Staff, HFI-35, 5600 Fishers Lane, Rockville, Maryland 20857 and reference docket number 93D-0236.

Opportunities were also provided for public discussion and debate and these issues are also briefly summarized in this Executive Summary. To guide sponsors and enhance understanding of the value of individualizing therapy, this Executive Summary concludes with FDA recommendations for assessing gender effects.

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