Science & Research

The Inclusion of Women in Clinical Trials

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 centers and external partners to understand sex and gender differences in disease prevalence and response to therapy through science and research.

  • 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 a disease therapy.
  • Sex differences can include differences in disease prevalence and response.
  • Analyses for sex differences can provide insight into the scientific basis for individual therapy differences and provide future directions for research.
 

FDA Activities

 

Tools and Resources for Researchers

 

OWH-Funded Research Studies:

  • 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/ Scientific Workshops:

Page Last Updated: 07/19/2016
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