Participation of women in clinical trials of drug therapies: a context for the controversies
- PMID: 11698923
Participation of women in clinical trials of drug therapies: a context for the controversies
Abstract
Women's participation in clinical trials, particularly those involving drugs, has been said to be both overrepresented and underrepresented. How can this be? Studies of participation are compared and contrasted to elucidate some reasons for this contradiction. The history of women's participation in clinical trials is chronicled through policies and regulations filled with restrictions. Since 1993, however, the National Institutes of Health has mandated, and the Food and Drug Administration has emphasized, inclusion of women in clinical trials, only to be thwarted by other regulations excluding many women. Gender-specific analyses are required to detect gender differences in effects of pharmaceutical and nonpharmaceutical interventions, but they are seldom performed. The exclusion of women from clinical trials means that women's healthcare is compromised by lack of sex-specific information about dosing of drugs and unique uses of drugs. A database, although currently quite limited, tracks the participation of women in clinical trials funded by federal agencies, industries, and nonprofit groups. Federal regulations have recently changed. Additional changes in access to all phases of clinical trials and enhanced monitoring of clinical trials are recommended.
Similar articles
-
Does exclusion or inclusion better protect women?J Gend Specif Med. 1998 Oct-Nov;1(2):18-22. J Gend Specif Med. 1998. PMID: 11281007 Review. No abstract available.
-
There is no women's health crisis.Public Interest. 1998 Winter;130:21-33. Public Interest. 1998. PMID: 11658109 No abstract available.
-
Enrollment of women in cardiovascular clinical trials funded by the National Heart, Lung, and Blood Institute.N Engl J Med. 2000 Aug 17;343(7):475-80. doi: 10.1056/NEJM200008173430706. N Engl J Med. 2000. PMID: 10944565
-
Assessment of analysis by gender in the Cochrane reviews as related to treatment of cardiovascular disease.J Womens Health (Larchmt). 2003 Jun;12(5):449-57. doi: 10.1089/154099903766651577. J Womens Health (Larchmt). 2003. PMID: 12869292 Review.
-
Women's health as a priority.Am Pharm. 1995 Sep;NS35(9 Suppl):S1-11; quiz S12-3. Am Pharm. 1995. PMID: 7502991 Review.
Cited by
-
Harnessing health plan enrollee data to boost membership in patient-powered research networks.BMC Health Serv Res. 2020 May 25;20(1):462. doi: 10.1186/s12913-020-05325-z. BMC Health Serv Res. 2020. PMID: 32450857 Free PMC article. Clinical Trial.
-
Women's involvement in clinical trials: historical perspective and future implications.Pharm Pract (Granada). 2016 Jan-Mar;14(1):708. doi: 10.18549/PharmPract.2016.01.708. Epub 2016 Mar 15. Pharm Pract (Granada). 2016. PMID: 27011778 Free PMC article.
-
Challenges to recruitment and retention of African Americans in the gene-environment trial of response to dietary interventions (GET READI) for heart health.Health Educ Res. 2011 Oct;26(5):923-36. doi: 10.1093/her/cyr061. Epub 2011 Aug 23. Health Educ Res. 2011. PMID: 21865154 Free PMC article. Clinical Trial.
-
European Medicines Agency policies for clinical trials leave women unprotected.J Epidemiol Community Health. 2006 Nov;60(11):911-3. doi: 10.1136/jech.2006.048769. J Epidemiol Community Health. 2006. PMID: 17053276 Free PMC article.
MeSH terms
LinkOut - more resources
Full Text Sources
Medical
