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  1. Women in Clinical Trials

Women in Clinical Trials: Research and Policy

From the FDA Office of Women's Health

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Diverse women discussing in small group

On this page: Introduction | Why is this work important? | Related FDA policy | Related links 

Introduction

OWH was established in 1994 to advocate for the participation of women in clinical trials and for the analyses of data by sex. OWH supports studies to track the participation of women in clinical trials and collaborates with FDA's centers and external partners to conduct trainings, workshops, outreach, and research to improve clinical trials design, recruitment, and analyses and to support FDA regulatory policy and decision-making.

Why is this work important?

  • Participation of women in clinical trials helps to ensure that clinical trials represent the population most likely to use a medical product.
  • Analyzing data by sex allows researchers to determine if there are any sex differences in the response to medical treatment.
  • Analyses for sex differences can provide insight into the scientific basis for individual therapy differences and provide future directions for research.  

Related FDA policy 

FDA develops guidance and policy to provide its perspectives and recommendations on a wide variety of topics. More information about FDA guidance documents is available on FDA’s guidance website, and includes a searchable list of all current FDA guidance documents.

Related links

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