Science & Research

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.
 

Check the links on this page to learn more about OWH activities and other resources related to women in clinical trials.

 

Guidances/ Regulations/ Reports

 

Conferences/ Scientific Workshops:

 

OWH-Funded Research:

  • 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
 

Collaborations

 

Publications

 

Presentations

  • Talk: Women in Clinical Trials:FDA Policies - Ameeta Parekh. IOM Forum on Neuroscience and Nervous System Disorders, San Francisco, CA, March 9, 2010
  • Talk: The American Regulatory Perspective on Women in Clinical Trials - Ameeta Parekh. Karolinska Institute of Sweden, October 2010
  • Round Table Discussion: Inclusion of Women in Clinical Trials & Drug Development - Regulatory Perspective, Ameeta Parekh. American Association of Pharmaceutical Scientists Annual Meeting, Los Angeles, November 10, 2009
  • Poster: Tracking Women’s Participation and Sex Analyses in Late Phase Clinical Trials of New Molecular Entity (NME) Drugs and Biologics Approved by the FDA between 2007 and 2009 R Poon, K Khanijow, S Umarjee, E Fadiran, M Yu, Lei Zhang, A Parekh, OSSD Fifth Annual Meeting, June 2-4, 2011, Oklahoma City, OK
  • Poster: Participation of Women in Clinical Trials: A Fifteen Year Assessment by the FDA Office of Women’s Health (OWH)Keshav Khanijow and Ameeta Parekh, Scientific Symposium: Celebrating the 20th Anniversary of the Office of Research on Women’s Health, NIH, September 27, 2010
  • Demographic Data on Sex in ASCPT Posters (2006): Discrimination or Not? Kathleen Uhl M.D., Ellen Pinnow MS, Katherine Hollinger D.V.M.
  • Evaluation of NDAs Submitted to the FDA in CDISC SDTM Format: Feasibility of Using Demographic Domain Data to Track the Inclusion of Women in Trials. Presented at CDISC 2006 International Interchange, September 25-29, 2006, Bethesda, MD. Ellen Pinnow MS
  • Enrollment of Women and Racial Minorities in Clinical Trials for Diabetes Medications (2007) Ellen Pinnow MS, Pellavi Sharma MPH, Ameeta Parekh Ph.D., Kimberly Thomas MPH, Lina Aljuburi Pharm D, Kathleen Uhl M.D.
  • Sex Differences of Inclusion Criteria in Clinical Trials: A Regulatory Review of Contraception Requirements (2006) Ellen Pinnow MS, Pamela Scott Ph.D., Janelle Derbis, Theresa Toigo RPh, MBA, Kathleen Uhl M.D.

 

Page Last Updated: 10/14/2014
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