Participation of women in clinical trials for new drugs approved by the Food and Drug Administration in 2000-2002

Journal of Women's Health

Volumn 18, Issue 3, 2009, Pages 303-310

  Yang, Yongsheng ^a   Carlin, Alan S ^a   Faustino, Patrick J ^a   Motta, Mónica I Pagán ^b   Hamad, Mazen L ^a   He, Ruyi ^a   Watanuki, Y ^a   Pinnow, E E ^a   Khan, Mansoor A ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b National Alliance for Hispanic Health   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CETROLIDE; CETRORELIX; DROSPIRENONE PLUS ETHINYLESTRADIOL; DUTASTERIDE; ETHINYLESTRADIOL PLUS ETONOGESTREL; ETHINYLESTRADIOL PLUS NORELGESTROMIN; FULVESTRANT; LOTRONIX; MIFEPRISTONE; TEGASEROD; UNCLASSIFIED DRUG;

ARTICLE; BREAST CANCER; CLINICAL TRIAL; DRUG ADSORPTION; DRUG APPROVAL; DRUG EFFICACY; DRUG LABELING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; IRRITABLE COLON; MEDICAL INFORMATION; MEDICAL RESEARCH; OVARY INSUFFICIENCY; PREGNANCY TERMINATION; PRIORITY JOURNAL; PROSTATE HYPERTROPHY; SEX DIFFERENCE; WOMEN'S HEALTH;

ADULT; AGE DISTRIBUTION; AGED; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; FEMALE; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HEALTH SERVICES ACCESSIBILITY; HUMAN EXPERIMENTATION; HUMANS; MALE; MIDDLE AGED; PATIENT SELECTION; SEX DISTRIBUTION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WOMEN'S HEALTH; YOUNG ADULT;

EID: 62449282362     PISSN: 15409996     EISSN: None     Source Type: Journal    
DOI: 10.1089/jwh.2008.0971     Document Type: Article

References (16)

1. Uhl K, Parekh A, Kweder S. Females in clinical studies: Where are we going? Nature 2007;81:600-602.
2. Merkatz RB, Temple R, Sobel S, et al. Women in clinical trials of new drugs: A change in Food and Drug Administration policy. N Engl J Med 1993;329:292-296.
3. Food and Drug Administration. General considerations for the clinical evaluation of drugs. Washington, DC: U.S. Government Printing Office, 1977.
4. Sherman LA, Temple R, Merkatz RB. Women in clinical trials: An FDA perspective. Science 1995;269:793-795.
5. Merkatz, RB. Inclusion of women in clinical trials: A historical overview of scientific, ethical, and legal issues. J Obstet Gynecol Neonatal Nurs 1997;27:78-84.
6. U.S. General Accounting Office. Women's health: FDA needs to ensure more study of gender differences in prescription drug testing, HRD-93-17. October 29, 1992;1-39. Available at http://archive.gao.gov/d35t11/147861.pdf
7. U.S. General Accounting Office. Women's health: Women sufficiently represented in new drug testing, but FDA oversight needs improvement. 2001:1-36. Available at www.gao.gov/new.items/d01754.pdf
8. Food and Drug Administration. Guideline for the format and content of the clinical and statistical sections of new drug application. Washington, DC: U.S. Government Printing Office, 1988.
9. Seminar on Women in clinical trials of FDA-regulated products: Who participates and who decides? Food Drug Law J 1993;48:161-163.
10. Food and Drug Administration. Guideline for the study and evaluation of sex differences in clinical evaluation of drugs. Fed Register 1993;58:39406-39413.
11. U.S. Department of Health and Human Services, Food and Drug Administration. Investigational new drug applications and new drug applications. Fed Register 1998;63:6854-6860.
12. U.S. Department of Health and Human Services, Food and Drug Administration. Investigational new drug applications; Amendment to clinical hold regulations for products intended for life-threatening diseases and conditions. Fed Register 2000;65:34963-34971.
13. Food and Drug Administration. FDA Modernization Act of 1997 and related documents. Available at www.fda.gov/opacom/7modact.html
14. FDA Scholarship in Women's Health Program. Participation of females in clinical trials and gender analysis of data in biologic product applications. Available at www.fda.gov/cber/clinical/femclin.htm
15. Evelyn B, Toigo T, Banks D, et al. Women's participation in clinical trials and sex-related labeling: A review of new molecular entities approved 1995-1999. Available at www.fda.gov/cder/reports/womens-health/women-clin- trials.htm
16. Prout MN, Fish SS. Participation of women in clinical trials of drug therapies: A context for the controversies. Medscape Womens Health 2001;6:1.