Women's involvement in clinical trials: historical perspective and future implications
- PMID: 27011778
- PMCID: PMC4800017
- DOI: 10.18549/PharmPract.2016.01.708
Women's involvement in clinical trials: historical perspective and future implications
Abstract
The importance of considering the differences between the male and female sex in clinical decision-making is crucial. However, it has been acknowledged in recent decades that clinical trials have not always adequately enrolled women or analyzed sex-specific differences in the data. As these deficiencies have hindered the progress of understanding women's response to medications, agencies in the United States have worked towards the inclusion of women in clinical trials and appropriate analysis of sex-specific data from clinical trials. This review outlines the history and progress of women's inclusion in clinical trials for prescription drugs and presents considerations for researchers, clinicians, and academicians on this issue.
Keywords: Clinical Trials as Topic; Female; Patient Participation; Research; United States; Women’s Health.
Conflict of interest statement
The authors have no conflict of interest with this article. No funding was provided.
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References
-
- Wizemann T, Pardue M. Exploring the biological contributions to human health: does sex matter? Washington DC: National Academies Press; 2001. - PubMed
-
- Pinn V. Sex and gender factors in medical studies: implications for health and clinical practice. JAMA. 2003;289(4):397–400. - PubMed
-
- Committee on Women’s Health Research, Board on Population Health and Public Health Practice, Institute of Medicine. Women’s health research: progress, pitfalls, and promise. Washington DC: National Academies Press; 2010.
-
- National Institute on Drug Abuse Treatment Clinical Trials Network. [accessed 2015 Dec 6];Successfully Including Women in Clinical Trials. A Guide for Researchers. Available at https://www.drugabuse.gov/sites/default/files/womens-brochure_1025-004_5... .
-
- Centers for Disease Control and Prevention. [accessed 2015 Nov 28];Ten ways STDs impact women differently from men. Available at http://www.cdc.gov/std/health-disparities/stds-women-042011.pdf .
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