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.
Similar articles
-
Public health context of women's mental health research.Psychiatr Clin North Am. 2003 Sep;26(3):781-99. doi: 10.1016/s0193-953x(03)00039-x. Psychiatr Clin North Am. 2003. PMID: 14563109 Review.
-
Participation of women in clinical trials of drug therapies: a context for the controversies.Medscape Womens Health. 2001 Oct;6(5):1. Medscape Womens Health. 2001. PMID: 11698923
-
Participation of women in clinical trials for new drugs approved by the food and drug administration in 2000-2002.J Womens Health (Larchmt). 2009 Mar;18(3):303-10. doi: 10.1089/jwh.2008.0971. J Womens Health (Larchmt). 2009. PMID: 19243271
-
A Multicenter Investigation of Factors Influencing Women's Participation in Clinical Trials.J Womens Health (Larchmt). 2018 Mar;27(3):258-270. doi: 10.1089/jwh.2017.6458. Epub 2017 Nov 17. J Womens Health (Larchmt). 2018. PMID: 29148879
-
Women's mental health research: the emergence of a biomedical field.Annu Rev Clin Psychol. 2006;2:135-60. doi: 10.1146/annurev.clinpsy.2.022305.095344. Annu Rev Clin Psychol. 2006. PMID: 17716067 Review.
Cited by
-
Editorial: Impact of female hormones on the brain.Front Endocrinol (Lausanne). 2024 Aug 14;15:1451286. doi: 10.3389/fendo.2024.1451286. eCollection 2024. Front Endocrinol (Lausanne). 2024. PMID: 39205679 Free PMC article. No abstract available.
-
Sex as a Biological Variable in Early-Phase Oncology Clinical Trials: Enhancing the Path to Personalised Medicine.Heliyon. 2024 Jun 7;10(12):e32597. doi: 10.1016/j.heliyon.2024.e32597. eCollection 2024 Jun 30. Heliyon. 2024. PMID: 39183838 Free PMC article. Review.
-
The relationship between gender and pharmacology.Curr Res Pharmacol Drug Discov. 2024 Jun 18;7:100192. doi: 10.1016/j.crphar.2024.100192. eCollection 2024. Curr Res Pharmacol Drug Discov. 2024. PMID: 39101002 Free PMC article.
-
Sex differences in airway disease: estrogen and airway surface liquid dynamics.Biol Sex Differ. 2024 Jul 18;15(1):56. doi: 10.1186/s13293-024-00633-z. Biol Sex Differ. 2024. PMID: 39026347 Free PMC article. Review.
-
Clinicopathological Differences between Right and Left Colorectal Cancer by Sex.J Clin Med. 2024 May 10;13(10):2810. doi: 10.3390/jcm13102810. J Clin Med. 2024. PMID: 38792352 Free PMC article.
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 .
LinkOut - more resources
Full Text Sources
Other Literature Sources
Research Materials