Science & Research
Women’s Participation 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 Studies
- Collaborations
- Publications
- Presentations
Guidances/ Regulations/ Reports
- 1977 FDA Guidance General Considerations for the Clinical Evaluation of Drugs Effectively excluded women of childbearing potential from participation in clinical trials (PDF - 1.4MB)
- 1992 GAO report Women’s Health: FDA Needs to Ensure More Study of Gender Differences in Prescription Drugs Testing. (PDF - 2.8MB)
- FDA Guidance for Industry. Gender Guideline 1993. Study and Evaluation of Gender Differences in the Clinical Trials
- 1998 Investigational New Drug Applications and New Drug Applications (21 CFR 312.33 and 21 CFR 314.50)
- 2000 Clinical Hold for Products Intended for Life-Threatening Diseases (21 CFR 312.42)
- 2001 GAO Report Drug Safety: Most Drugs Withdrawn in Recent Years Had Greater Health Risks for Women (PDF - 421KB)
- Women's Health Research: Progress, Pitfalls, and Promise (2010) Committee on Women's Health Research; Institute of Medicine (IOM)
Conferences/ Scientific Workshops:
- Conference: Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities, September 22-23, 2011, Washington, DC (Held in Collaboration with the Society for Women's Health Research)
- Workshop: Exploration of Public Policy Development Regarding the Study and Analysis of Sex Differences in the Clinical Evaluation of Cardiovascular Medical Products, June 2, 2008, Kathryn M. O’Callaghan, B.S., CDRH
- Workshop: Gender Differences in Cardiovascular Device Trials, December 9, 2008, Kathryn M. O’Callaghan, B.S., CDRH
- Workshop: Gender Studies in Product Development: Scientific Issues and Approaches. November 1995
- 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
- CDISC: Clinical Data Interchange Standards Consortium. The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.
G Soon, M Min, K Struble, K Chan-Tack, T Hammerstrom, K Qi, S Zhou, R Bhore, J Murray, D Birnkrant, Meta-Analysis of Gender Differences in Efficacy Outcomes for HIV-Positive Subjects in Randomized Controlled Clinical Trials of Antiretroviral Therapy (2000–2008). AIDS Patient Care and STDs 2012; 26(8):444-453.
- Book Chapter: A. Parekh. Women in Clinical Trials US-FDA Regulatory Perspective, Handbook of Gender Medicine (2011)
- Book Chapter: A. Parekh Women in Clinical Drug Trials: US-FDA Update on Policies and Practices Institute of Medicine of the National Academies (2011)
- R. Poon, K. Khanijow, S. Umarjee, E. Fadiran, M. Yu, L. Zhang, A. Parekh Participation of Women and Sex Analyses in Late Phase Clinical Trials of New Molecular Entity (NME) Drugs and Biologics Approved by the FDA in 2007-2009 Drug Information Association (June 2011)
- S.Umarjee, S. Lemtouni, E. Fadiran, A. Parekh Patient demographics in cardiovascular drug trials: FDA reviews from 2007 to 2008 Clin Pharm Ther 2010; 87(supp 1), S75, No. PIII-23
- Yang Y, Carlin AS, Faustino PJ, Paga´n Motta MI, Hamad ML, He R, Watanuki Y, Pinnow EE, Khan MA, Participation of Women in Clinical Trials for New Drugs Approved by the Food and Drug Administration in 2000–2002. J of Women’s Health 2009; 18(3):303-310
- E Pinnow, P. Sharma, A. Parekh, N. Gevorkian, K. Uhl Increasing Participation of Women in Early Phase Clinical Trials Approved by the FDA Women’s Health Issues 2009; 19(2):89-93
- S. Lemtouni, A. Defelice, K. Uhl, J. Willard Enrollment of Women and Ethnic Minorities and their Drop-out Profiles: More than a Quarter of a Century Experience (1973-2001) in Antihypertensive Drug Trials Circulation. 2009;120:S498-S499
- E. Pinnow, A. Parekh, P. Sharma, N. Gevorkian, K. Uhl Inclusion of Subpopulation in Early Phase Clinical Trials submitted to the FDA: A Review of NMES Approved 2006-2007 Clin Phar Ther 2008;83, S86-S87
- K. Uhl, A. Parekh, S. Kweder Females in Clinical Studies: Where are we going? Clin Pharm Ther 2007; 81(4):600-602
- B. Evelyn, T. Toigo, D. Banks, D. Pohl, K. Gray, B. Robins, and J. Ernat Participation of Racial/Ethnic Groups in Clinical Trials and Race-Related Labeling: A Review of New Molecular Entities Approved 1995-1999 J Nat Med Assoc. 2001; 93(12):18S-24S
- L. Sherman, R. Temple, R. Merkatz Women in Clinical Trials: An FDA Perspective Science 1995; 269:793-795
- R Merkatz, R Temple, S Sobel, K Feiden, D Kessler, and the Working Group on Women in Clinical Trials Women in Clinical Trials of New Drugs - A Change in Food and Drug Administration Policy, N Engl J Med 1993; 329:292-296
- 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.