Participation of women and sex analyses in late-phase clinical trials of new molecular entity drugs and biologics approved by the FDA in 2007-2009

Journal of Women's Health

Volumn 22, Issue 7, 2013, Pages 604-616

  Poon, Rita ^a   Khanijow, Keshav ^a   Umarjee, Sphoorti ^a   Fadiran, Emmanuel ^a   Yu, Monica ^a   Zhang, Lei ^a   Parekh, Ameeta ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ALVIMOPAN; BENZYL ALCOHOL; BESIFLOXACIN; FOSPROPOFOL;

ACUTE CORONARY SYNDROME; ARTICLE; DEPRESSION; DIABETES MELLITUS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTENSION; MAJOR CLINICAL STUDY; MALE; MUCKLE WELLS SYNDROME; NONHODGKIN LYMPHOMA; OVERACTIVE BLADDER; PARKINSON DISEASE; PEDICULOSIS CAPITIS; PRIORITY JOURNAL; PULMONARY HYPERTENSION; SCHIZOPHRENIA; SEX DIFFERENCE; SOCIAL PARTICIPATION; UNITED STATES;

ADULT; BIOLOGICAL AGENTS; CLINICAL TRIALS AS TOPIC; DATABASES, PHARMACEUTICAL; DRUG APPROVAL; FEMALE; HUMAN EXPERIMENTATION; HUMANS; LICENSURE; MALE; PATIENT PARTICIPATION; PATIENT SELECTION; PEDIATRICS; PHARMACEUTICAL PREPARATIONS; RISK ASSESSMENT; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84880096975     PISSN: 15409996     EISSN: 1931843X     Source Type: Journal    
DOI: 10.1089/jwh.2012.3753     Document Type: Article

References (28)

1. Anderson GD. Sex and Racial differences in pharmacological response: Where is the evidence? Pharmacogenetics, pharmacokinetics, and pharmacodynamics. J Womens Health (Larchmt) 2005;14: 19-29.
2. Benton R, Sale M, Flockhart D, Woosley R. Greater quinidine- induced QTc interval prolongation in women. Clin Pharmacol Ther 2000;67: 413-418.
3. Chauhan V, Krahn AD, Walker B, Klein GJ, Skanes A, Yee R. Sex differences in QTc interval and QT dispersion: Dynamics during exercise and recovery in healthy subjects. Am Heart J 2002;114: 858-864.
4. Rautaharju PM, Zhou SH, Wong S, et al. Sex differences in the evolution of the electrocardiographic QT interval with age. Can J Cardiol 1992;8: 690-695.
5. Kahn SE, Zinman B, Lachin JM, et.al.; Diabetes Outcome Progression Trial (ADOPT) Study Group. Rosiglitazoneassociated fractures in type 2 diabetes: An analysis from A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care 2008;31: 845-851.
6. Alexander K, Chen A, Roe M, et al. Excess dosing of antiplatelet and antithrombin agents in the treatment of non-STsegment elevation acute coronary syndromes. JAMA 2005; 294;3108-3116.
7. Campbell N, Hull R, Brant R, et al. Different effects of heparin in males and females. Clin Invest Med 1998;l21: 71-78.
8. U.S. Government Accountability Office (GAO). General accounting report, 2001 . Drug safety: Most drugs withdrawn in recent years had greater health risks for women. Available at: http://www.gao.gov/new.items/d01286r.pdf Accessed December 20, 2011.
9. UNSW Embryology. Abnormal development: Thalidomide. Available at: http://embryology.med.unsw.edu.au/Defect/ page5i.htm Accessed December 20, 2011.
10. U.S. Food and Drug Administration (FDA). General considerations for the clinical evaluation of drugs, 1977. HEW Publication No. (FDA) 77-3040. Available at: www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm071682.pdf Accessed December 23, 2011.
11. Pinn V. The role of NIH Office of Research on Women's Health. Acad Med 1994;69: 698-702.
12. U.S. Food and Drug Administration. Guideline for the study and evaluation of gender differences in clinical trials, 1993. Available at: www.fda.gov/downloads/Drugs/Guidance- ComplianceRegulatoryInformation/Guidances/ ucm072044.pdf Accessed August 20, 2012.
13. U.S. Government Accountability Office (GAO). Women's health: FDA needs to ensure more study of gender differences in prescription drug testing. HRD-93-17, 1992. Available at: http://archive.gao.gov/d35t11/147861.pdf Accessed December 28, 2011.
14. U.S. Government Accountability Office (GAO). Women's health: Women sufficiently represented in new drug testing, but FDA oversight needs improvement. GAO-01-754, 2001. Available at: www.gao.gov/new.items/d01754.pdf Accessed December 28, 2011.
15. Evelyn B, Toigo T, Banks D, et al., 2001. Women's participation in clinical trials and sex-related labeling: A review of new molecular entities approved 1995-1999. www.fda.gov/ ForConsumers/ByAudience/ForPatientAdvocates/ Participating inClinicalTrials/ucm197788.htm Accessed December 28, 2011.
16. Yang Y, Carlin A, Faustino P, Pagán-Motta P, Hamad M He R, et al. Participation of women in clinical trials for new drugs approved by the Food and Drug Administration between 2000 and 2002. J Womens Health (Larchmt) 2009;18: 303-310.
17. U.S. Food and Drug Administration. Participation of females in clinical trials and gender analysis of data in biologic product applications, 2009. www.fda.gov/BiologicsBloodVaccines/ DevelopmentApprovalProcess/ InvestigationalNewDrugINDor DeviceExemptionIDEProcess/ucm094300.htm Accessed December 28, 2011.
18. Falagas ME, Matthaiou DK, Rafailidis PI, Panos G, Pappas G. Worldwide prevalence of head lice [letter]. Emerg Infect Dis 2008;14:1493-1494. Available at www.cdc.gov/EID/ content/14/9/1493.htm Accessed December 28, 2011.
19. Soon G, Min M, Struble KA, et al. Meta-analysis of gender differences in efficacy outcomes for HIV-positive subjects in randomized controlled clinical trials of antiretroviral therapy (2000-2008). AIDS Patient Care STDs 2012;8: 444-453.
20. Centers for Disease Control and Prevention. HIV among women (August, 2011). Accessed July 30, 2012 at: www.cdc .gov/hiv/topics/women/index.htm.
21. Wallace KL, Riedel AA, Joseph-Ridge N, Wortmann R. Increasing prevalence of gout and hyperuricemia over 10 years among older adults in a managed care population. J Rheumatol 2004;31: 1582-1587.
22. FDA Clinical review of Febuxostat (Uloric-), www.access data.fda.gov/drugsatfda-docs/nda/2009/021856s 000-MedR- P1.pdf Accessed December 20, 2012.
23. U.S. Food and Drug Administration. Orphan Drug Act, 1983. www.fda.gov/regulatoryinformation/legislation/ federalfooddrugandcosmeticactfdcact/significantamend mentstothefdcact/ orphandrugact/default.htm Accessed December 28, 2012.
24. U.S. Department of Health and Human Services, Food and Drug Administration. Investigational new drug applications and new drug applications, final rule. Fed Regist 1998; 63(8): 6854-6862.
25. Coakley M, Fadiran EO, Parrish LJ, et al. (2012). Dialogues on diversifying clinical trials: Successful strategies for engaging women and minorities in clinical trials. J Womens Health 2012; 21: 713-716.
26. Slides for the November 15, 2010 meeting of the Science Board to the FDA. Available at: www.fda.gov/Advisory- Committees/CommitteesMeetingMaterials/ ScienceBoardtotheFoodandDrugAdministration/ ucm233252.htm Accessed August 20, 2012.
27. Food and Drug Administration. CDER data standards plan version 1.0-Draft. Available at: www.fda.gov/downloads/ Drugs/ DevelopmentApprovalProcess/ FormsSubmission- Requirements/ ElectronicSubmissions/UCM214120.pdf Accessed August 20 2012.
28. Written notice of participation by the Clinical Data Interchange Standards Consortium (CDISC) and written statement for discussion topics to be addressed in the FDA public hearing: Electronic submission of regulatory information, and creating an electronic platform for enhanced information management. Available at: www.fda.gov/ohrms/ dockets/ dockets/06n0464/06N-0464- EC10-Attach-1.pdf Accessed August 20, 2012.