Analysis and reporting of sex differences in phase III medical device clinical trials - How are we doing?

Journal of Women's Health

Volumn 22, Issue 5, 2013, Pages 399-401

  Nolan, Martha R ^a   Nguyen, Thuy Linh ^a  

^a Society for Women's Health Research   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL DECISION MAKING; CLINICAL TRIAL (TOPIC); FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL DEVICE; MEDICAL LITERATURE; MEDICAL RESEARCH; PATIENT CARE; PRIORITY JOURNAL; SEX DIFFERENCE; DEVICES; EVIDENCE BASED MEDICINE; FACTUAL DATABASE; FEMALE; MALE; PATIENT SELECTION; PHASE 3 CLINICAL TRIAL (TOPIC); PROCEDURES; SEXUAL DEVELOPMENT; STANDARDS; STATISTICS AND NUMERICAL DATA; UNITED STATES; WOMEN'S HEALTH;

BIOMEDICAL RESEARCH; CLINICAL TRIALS, PHASE III AS TOPIC; DATABASES, FACTUAL; EQUIPMENT AND SUPPLIES; EVIDENCE-BASED MEDICINE; FEMALE; HUMANS; MALE; PATIENT SELECTION; SEX CHARACTERISTICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WOMEN'S HEALTH;

EID: 84877871705     PISSN: 15409996     EISSN: 1931843X     Source Type: Journal    
DOI: 10.1089/jwh.2013.4400     Document Type: Article

References (15)

1. National Institutes of Health. NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research. Available at http://grants.nih.gov/grants/funding/women-min/guidelines-amended-10-2001.htm (accessed February 8, 2013).
2. U.S. Food and Drug Administration. 100 Years of protecting and promoting women's health. Available at www.fda.gov/downloads/ForConsumers/ByAudience/ ForWomen/UCM303869.pdf (accessed February 8, 2013).
3. National Institutes of Health. Budget and spending. Available at http://report.nih.gov/budget-and-spending/index .aspx (accessed February 12, 2013).
4. U.S. Food and Drug Administration. Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs. Available at www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126835.pdf (accessed February 8, 2013).
5. U.S. Food and Drug Administration. Investigational new drug applications and new drug applications. Available at www.fda.gov/ScienceResearch/ SpecialTopics/Running ClinicalTrials/ucm120254.htm (accessed February 11, 2013).
6. Institute of Medicine. Exploring the biological contributions to human health: Does sex matter? Available at www.iom .edu/Reports/2001/Exploring-the- Biological-Contributionsto-Human-Health-Does-Sex-Matter.aspx (accessed February 8, 2013).
7. U.S. Government Accountability Office (GAO). Women's health: NIH has increased its efforts to include women in research. Washington, DC: GAO, 2000.
8. U.S. Government Accountability Office (GAO). Women's health. Women sufficiently represented in new drug testing, but FDA oversight needs improvement. Washington, DC: GAO, 2001.
9. Institute of Medicine. Women's health research: Progress, pitfalls, and promise. Available at www.nap.edu/catalog .php?record-id = 12908 (accessed February 8, 2013).
10. Wizemann TM. Sex-specific reporting of scientific research: A workshop summary. Washington, DC: Institute of Medicine, 2012.
11. U.S. Food and Drug Administration. Draft guidance for industry and Food and Drug Administration staff - Evaluation of sex differences in medical device clinical studies. Available at www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/UCM283707.pdf (accessed February 8, 2013).
12. Dhruva SS, Bero LA, Redberg RF. Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices. Circ Cardiovasc Qual Outcomes 2011; 4:165-171.
13. Putting gender on the agenda. Nature 2010;465:665.
14. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: Writing and editing for biomedical publication. Available at www.icmje.org/urm-full.pdf (accessed February 8, 2013).
15. Gendered Innovations in Science, Health & Medicine, Engineering, and Environment. Sex and gender analysis policies of peer-reviewed journals. Available at http://gender edinnovations.stanford.edu/sex-and-gender-analysis- policiespeer-reviewed-journals.html (accessed February 11, 2013).