Inclusion of women in cardiac research: Current trends and need for reassessment

Gender Medicine

Volumn 2, Issue 2, 2005, Pages 71-75

  Blake, Mary Beth ^a   Ince, Melissa ^b   Dean, Cathy J ^c  

^a Health Care Practice Group   (United States)

^b Administrative Law Practice Group   (United States)

^c Litigation Department   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIARRHYTHMIC AGENT; ANTIHISTAMINIC AGENT; CARDIAC AGENT; CARDIOVASCULAR AGENT; FIBRINOGEN RECEPTOR ANTAGONIST; IBUTILIDE; NEW DRUG;

ARTICLE; CARDIOVASCULAR DISEASE; CORONARY ARTERY DISEASE; DRUG EFFICACY; DRUG RESEARCH; ETHNIC DIFFERENCE; FEMALE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ORGANIZATION; HEART ARRHYTHMIA; HEART DISEASE; HEART FAILURE; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HISTORY OF MEDICINE; HUMAN; HYPERTENSION; INFORMED CONSENT; LAW; LEGAL ASPECT; MALE; MEDICAL ETHICS; MEDICAL RESEARCH; MENSTRUAL CYCLE; MITRAL VALVE PROLAPSE; NEGLIGENCE; PATIENT COMPLIANCE; PRIORITY JOURNAL; RHEUMATIC HEART DISEASE; RISK FACTOR; SEX DIFFERENCE; TORSADE DES POINTES;

BIOMEDICAL RESEARCH; ETHICS, RESEARCH; FEMALE; GOVERNMENT REGULATION; HEART DISEASES; HUMANS; PATIENT SELECTION; RESEARCH SUBJECTS; SEX FACTORS; UNITED STATES; WOMEN'S HEALTH;

EID: 20944449681     PISSN: 15508579     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1550-8579(05)80013-0     Document Type: Article

References (21)

1. Krummel D.A. Koffman D.M. Bronner Y. et al. Cardiovascular health interventions in women: What works? J Womens Health Gend Based Med. 10 2001 117-136
2. Malarcher A.M. Casper M.L. Matson Koffman D.M. et al. Women and cardiovascular disease: Addressing disparities through prevention research and a national comprehensive state-based program J Womens Health Gend Based Med. 10 2001 717-724
3. McCormick K.M. Bunting S.M. Application of feminist theory in nursing research: The case of women and cardiovascular disease Health Care Women Int. 23 2002 820-834
4. Pinn V.W. Sex and gender factors in medical studies: Implications for health and clinical practice JAMA 289 2003 397-400
5. King K.M. Paul P. A historical review of the depiction of women in cardiovascular literature West J Nurs Res. 18 1996 89-101
6. Agency for Healthcare Research and Quality Lack of studies on women limits usefulness of research on coronary heart disease. July 10, 2003. Available at: http://www.ahrq.gov/news/press/pr2003/chdwmpr.htm. Accessed April 10, 2005
7. US Food and Drug Administration General Considerations for the Clinical Evaluation of Drugs. Washington, DC: Government Printing Office; 1977 Publication No. HEW (FDA) 77-3040
8. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. April 10, 1979. Available at: http://ohsr.od.nih.gov/guidelines/belmont.html
9. Fourcroy J.L. Women and the development of drugs: Why can't a woman be more like a man? Ann N Y Acad Sci. 736 1994 174-195
10. National Institutes of Health NIH Guide for Grants and Contracts vol 19. no. 18 1990 NIH Bethesda, Md
11. National Institutes of Health Revitalization Act of 1993. Pub L No. 103-43, 107 Stat 122.
12. US Food and Drug Administration Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs Fed Regist. 58 1993 39406-39416
13. Investigational new drug applications and new drug applications 63 Federal Register 6854 1998 (codified at 21 CFR §312 and §314)
14. American College of Obstetricians and Gynecologists Committee on Ethics Research involving women. Available at: http://www.acog.org/from_home/ publications/ethics/ethics086.pdf Accessed April 15, 2005
15. National Institutes of Health, Office of Research on Women's Health Research findings: Sex and gender differences. Available at: http://www4.od.nih.gov/orwh/Sex&GenderDiff.html Accessed on April 15, 2005
16. Berg M.J. Ketley J.N. Merkatz R. Mittelman A. Pharmacologic issues In: Agenda for Research on Women's Health for the 21st Century: A Report of the Task Force on the NIH Women's Health Research Agenda for the 21st Century vol 2 1999 National Institutes of Health Bethesda, Md. NIH publication 99-4386
17. Harris D.J. Douglas P.S. Enrollment of women in cardiovascular clinical trials funded by the National Heart, Lung, and Blood Institute New Engl J Med. 343 2000 475-480
18. Toigo E.B. Banks T. Pohl D. et al. Women's participation in clinical trials and gender-related labeling: A review of new molecular entities approved 1995-1999. June 2001. Available at: http://www.fda.gov/cder/ reports/womens_health/women_clin_trials.htm. Accessed April 15, 2005
19. US General Accounting Office Report to Congressional Requesters: Women's Health-Women Sufficiently Represented in New Drug Testing, But FDA Oversight Needs Improvement July 2001. Publication no. GAO-01-754
20. Agency for Healthcare Research and Quality Results of systematic review of research on diagnosis and treatment of coronary heart disease in women, summary. Available at: http://www.ahrq.gov/clinic/epcsums/ chdwomsum.html Accessed April 15, 2005 2003
21. Agency for Healthcare Research and Quality Diagnosis and treatment of coronary heart disease in women: Systematic reviews of evidence on se lected topics, summary. Available at http://www.ahrq.gov/clinic/epcsums/ chdwtopsum.html. Accessed April 15, 2005 Evidence report/Technology assessment No. 81 2003