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Inclusion of Women in Clinical Trials: Policies for Population Subgroups REFERENCES 1. U.S. Congress Public Law 103–43. National Institutes of Health Revitalization Amendment. Washington, D.C. June 10, 1993. 2. National Institutes of Health. Policy concerning women in study populations. NIH Instruction and Information Memorandum OER 90–5, December 11, 1990. 3. Food and Drug Administration. Guidelines for the format and content of the clinical and statistical sections of new drug applications, July 1988. 4. University of Nebraska Institutional Review Board. Policy for the inclusion of women of child bearing potential in clinical research. October 1, 1990. Omaha, University of Nebraska. 5. Council on Ethical and Judicial Affairs, American Medical Association. Gender disparities in clinical decision making. J Am Med Assoc 1991;266: 559–62. 6. Rodin J, Icovics JR. Women’s health. Review and research agenda as we approach the 21st century. Am Psychol 1990;45:1018–34. 7. National Center for Health Statistics. Vital and health statistics. Current estimates from the National Health Interview Survey, 1989. Rockville, Md.: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, October 1990. 8. Weissman MM. Gender differences in rates of mental disorders. In: Assessing future research needs: Mental and addictive disorders in women. Summary of Institute of Medicine conference, October 1991. Washington, D.C: Institute of Medicine, 1991:1–120. 9. Fiebach NH, Viscoli CM, Horwitz RI. Differences between women and men in survival after myocardial infarction: biology or methodology? J Am Med Assoc 1992; 263:1092–6. 10. Mendelson HJ, Mello NK. Chronic alcohol effects on anterior pituitary and ovarian hormones in healthy women. J Pharmacol Exp Ther 1988; 245: 407–12. 11. Goble FC. Sex as a factor in metabolism, toxicity, and efficacy of pharmacodynamic and chemotherapeutic agents. Adv Pharmacol Chemother 1975; 13:173–252. 12. Wilson K. Sex-related differences in drug disposition in man. Clin Pharmacokin 1984; 9:189–202. 13. The Coronary Drug Project Research Group. Influence of adherence to treatment and response of cholesterol on mortality in the Coronary Drug Project. New Engl J Med 1980; 393:1038–41. 14. Lipid Research Clinics Program. The Lipid Research Clinics coronary primary prevention trial results. J Am Med Assoc 1983; 251:351–74. 15. CASS Principal Investigators. Myocardial infarction and mortality in
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Inclusion of Women in Clinical Trials: Policies for Population Subgroups the Coronary Artery Surgery Study (CASS) randomized trial. New Engl J Med 1985; 312:1665–71. 16. Veterans Administration Coronary Artery Bypass Surgery Cooperative Study Group. Eleven-year survival in the Veterans Administration randomized trial of coronary bypass surgery for stable angina. New Engl J Med 1984; 311: 1333–9. 17. Healy B. The Yentl syndrome. New Engl J Med 1991; 325:274–5. 18. U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration. Memo from the Director of Office of Drug Evaluation I to Carl Peck, Center for Drug Evaluation and Research: Studies of older patients in NDAs for NMEs approved in 1988. Washington, D.C., September 8, 1989. 19. Hamilton JA. Guidelines for avoiding methodological and policymaking biases in gender-related health research. In: Report of the Public Health Service Task Force on Women’s Health Issues, Vol. II. Rockville, Md: U.S. Public Health Service, 1985:IV-54-IV-64. 20. Peto R. Clinical trial methodology. Biomed Pharmacother 1978; 28: 24–36. 21. Simon R. Patient subsets and variation in therapeutic efficacy. Br J Clin Pharmacol 1982; 14:473–82. 22. Fisher B, Wolmark N, Rockette H, et al. Postoperative adjuvant chemotherapy or radiation therapy for rectal cancer: results from NSABP protocol R-01. J Natl Cancer Inst 1988; 80(l):21–9. 23. Early Breast Cancer Trialists’ Collaborative Group. Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy. Lancet 1992; 339:1–15, 71–85. 24. Davis CE, Leffingwell D. Empirical bayes estimates of subgroup effects in clinical trials. Controlled Clin 1990; 11:347–53. 25. Yusuf S, Wittes J, Probstfield J, Tyroler H. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. J Am Med Assoc 1991; 266:93–8. 26. Herbst AL, Ulfelder H, Postkanzer DC. Adenocarcinoma of the vagina: association of maternal stilbestrol therapy with tumor appearance in young women. New Engl J Med 1971; 284:978–81. 27. Institute of Medicine. Patient outcomes research teams: managing conflict of interest. Donaldson MS, Capron AM, eds. Washington, D.C.: National Academy Press, 1991. 28. Collins R, Gray R, Godwin J, Peto R. Avoidance of large biases and large random errors in the assessment of moderate treatment effect: the need for systematic overviews. Stat Med 1987; 6:245–50.
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