Science & Research

FDA Research, Policy, and Workshops on Women in Clinical Trials

 

Controlled clinical trials provide a critical base of evidence for evaluating whether a medical product is effective before the product is approved for marketing. Women’s participation in clinical trials has improved in many areas, but we need to continue this momentum. The FDA Office of Women’s Health (OWH) was established by congressional mandate to advocate for the participation of women in clinical trials and 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 so important?

  • Adequate participation of women in clinical trials allows representation of the population most likely to use a disease therapy.

  • 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.  

FDA Activities

FDA Guidance, Regulations and Reports

FDA has a variety of statutory, regulatory, and policy-related tools that provide a framework for guiding medical product sponsors in the inclusion and analysis of women and demographic subgroups in clinical trials.

 

Tools and Resources for Researchers

 

OWH-Funded Clinical Trials Research

  • Individual patient-data meta-analysis and postmarket analysis as a method for improving data quality in demographic subgroups (Support for implementation of FDASIA Section 907 Action Plan- Daniel Canos, PhD/CDRH (2015)

  • Evaluation of gender-related clinical pharmacology information in the labelings on adverse events and outcomes. Lei Zhang, PhD, CDER (2010)

  • Identification of Sex Differences in Adverse Outcomes for New Molecular Entities (NMEs) Approved from 2000-2002. Yongsheng Yang, Ph.D., CDER (2007)

  • Participation of Women in Clinical Trials and Gender Analysis of Data in Original NDAs Approved 2000-2002. Yongsheng Yang, Ph.D., CDER (2006)

  • Gender Differences and Impact of Pharmacogenomics in Rheumatoid Arthritis. Shashi Amur Ph.D., CDER (2006)

  • Impact of Gender Analysis and Pharmacogenomics on Clinical Efficacy, Safety, and Pharmacokinetics of Drugs Used for the Treatment of Alzheimer’s Disease. Angela Men, Ph.D., CDER (2006)

  • Women in HIV Trials: A Comprehensive Review and Meta-Analysis. Greg Soon, Ph.D., CDER (2006)

  • Statistical Analysis of Gender Specific Data from New Drug Application (NDA) Submissions. Ohidul Siddiqui Ph.D., CDER (2006)

  • Evaluation of Availability and Quality of Information Available on Females Included in Mechanical Device Implant Trials. Kathryn O’Callaghan B.S., CDRH (2006)

  • Women’s participation in clinical drug trials for unstable angina and myocardial infarction. Ann Farrell, MD, CDER (2000)

  • Development and expansion of a pilot tracking system for monitoring the barriers to the enrollment of women in clinical trials. Toigo, Teresa, RPH, MBA, OC/OEA (1995)

  • Participation of Females in Clinical Trials and Gender Analysis of Data in Biologic Product Applications

 

Conferences and Scientific Workshops

 

OWH Sex and Gender Speaker Series for FDA Reviewers

The FDA Office of Women’s Health established a new CE lecture series for FDA reviewers to provide the latest evidence about sex differences in disease presentation, treatment, and outcomes. Launched in March 2016, the series features scientific developments and regulatory best practices in sex and gender-specific women’s health.

Page Last Updated: 12/16/2016
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