Women in Clinical Trials: Research and Policy

From the FDA Office of Women's Health

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. Policy and guidance related to women in clinical trials include:

Food and Drug Omnibus Reform Act (FDORA) of 2022 (December 2022, PDF 3.72MB)
Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials (April 2022, draft guidance)
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment (June 2021, final guidance)
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry (2020, final guidance)
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format (July 2020, draft guidance)
Clinical Lactation Studies: Considerations for Study Design (May 2019, draft guidance)
Postapproval Pregnancy Safety Studies Guidance for Industry (May 2019, draft guidance)
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials (April 2018, draft guidance)
Collection of Race and Ethnicity Data in Clinical Trials – Guidance for Industry and Food and Drug Administration Staff (October 2016, final guidance)
Evaluation of Sex-Specific Data in Medical Device Clinical Studies – Guidance for Industry and Food and Drug Administration Staff (August 2014, final guidance)
Amendments to Content and Format of a New Drug Application (21 CFR 314.50 (d)(5) – Demographic Rule (1998 PDF, 162 KB)