REFERENCES

Bairey Merz, C. N., L. J. Shaw, S. E. Reis, V. Bittner, S. F. Kelsey, M. Olson, B. D. Johnson, C. J. Pepine, S. Mankad, B. L. Sharaf, W. J. Rogers, G. M. Pohost, A. Lerman, A. A. Quyyumi, and G. Sopko. 2006. Insights from the NHLBI-sponsored Women’s Ischemia Syndrome Evaluation (WISE) study: Part II: Gender differences in presentation, diagnosis, and outcome with regard to gender-based pathophysiology of atherosclerosis and macrovascular and microvascular coronary disease. J Am Coll Cardiol 47(3 Suppl):S21-29.

Becker, J. B., A. P. Arnold, K. J. Berkley, J. D. Blaustein, L. A. Eckel, E. Hampson, J. P. Herman, S. Marts, W. Sadee, M. Steiner, J. Taylor, and E. Young. 2005. Strategies and methods for research on sex differences in brain and behavior. Endocrinology 146(4):1650-1673.

Becker, J. B., K. J. Berkley, N. Geary, E. Hampson, J. P. Herman, and E. Young, Eds. 2008. Sex Differences in the Brain: From Genes to Behavior. New York: Oxford University Press, Inc.

Beery, A. K., and I. Zucker. 2011. Sex bias in neuroscience and biomedical research. Neurosci Biobehav Rev 35(3):565-572.

Berry, D. A. 2005. Introduction to Bayesian methods III: Use and interpretation of Bayesian tools in design and analysis. Clin Trials 2(4):295-300; discussion 301-304, 364-378.

Canto, J. G., R. J. Goldberg, M. M. Hand, R. O. Bonow, G. Sopko, C. J. Pepine, and T. Long. 2007. Symptom presentation of women with acute coronary syndromes: Myth vs reality. Arch Intern Med 167(22):2405-2413.

Clayton, J. Presentation at Sex-Specific Reporting of Scientific Research: A Workshop. Institute of Medicine, Washington, DC.

FDA (U.S. Food and Drug Administration). 2010. Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM071121.pdf (accessed November 14, 2011).

Freedman, L. S., R. Simon, M. A. Foulkes, L. Friedman, N. L. Geller, D. J. Gordon, and R. Mowery. 1995. Inclusion of women and minorities in clinical trials and the NIH Revitalization Act of 1993—The perspective of NIH clinical trialists. Control Clin Trials 16(5):277-285; discussion 286-289, 293-309.

Gandhi, M., N. Ameli, P. Bacchetti, G. B. Sharp, A. L. French, M. Young, S. J. Gange, K. Anastos, S. Holman, A. Levine, and R. M. Greenblatt. 2005. Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols. AIDS 19(16):1885-1896.

GAO (U.S. General Accounting Office). 1992. Women’s Health: FDA Needs to Ensure More Study of Gender Differences in Prescription Drug Testing. GAO/HRD-93-17. http://archive.gao.gov/d35t11/147861.pdf (accessed November 2, 2011).

Gigerenzer, G. 2002. Calculated Risks: How to Know When Numbers Deceive You. New York: Simon & Schuster.



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WORKSHOP SUMMARY 41 REFERENCES Bairey Merz, C. N., L. J. Shaw, S. E. Reis, V. Bittner, S. F. Kelsey, M. Olson, B. D. Johnson, C. J. Pepine, S. Mankad, B. L. Sharaf, W. J. Rogers, G. M. Pohost, A. Lerman, A. A. Quyyumi, and G. Sopko. 2006. Insights from the NHLBI-sponsored Women’s Ischemia Syndrome Evaluation (WISE) study: Part II: Gender differences in presentation, diagnosis, and outcome with re- gard to gender-based pathophysiology of atherosclerosis and macrovascular and microvascular coronary disease. J Am Coll Cardiol 47(3 Suppl):S21-29. Becker, J. B., A. P. Arnold, K. J. Berkley, J. D. Blaustein, L. A. Eckel, E. Hampson, J. P. Herman, S. Marts, W. Sadee, M. Steiner, J. Taylor, and E. Young. 2005. Strategies and methods for research on sex differences in brain and behavior. Endocrinology 146(4):1650-1673. Becker, J. B., K. J. Berkley, N. Geary, E. Hampson, J. P. Herman, and E. Young, Eds. 2008. Sex Differences in the Brain: From Genes to Behavior. New York: Oxford University Press, Inc. Beery, A. K., and I. Zucker. 2011. Sex bias in neuroscience and biomedical research. Neurosci Biobehav Rev 35(3):565-572. Berry, D. A. 2005. Introduction to Bayesian methods III: Use and interpretation of Bayesian tools in design and analysis. Clin Trials 2(4):295-300; discussion 301-304, 364-378. Canto, J. G., R. J. Goldberg, M. M. Hand, R. O. Bonow, G. Sopko, C. J. Pepine, and T. Long. 2007. Symptom presentation of women with acute coronary syndromes: Myth vs reality. Arch Intern Med 167(22):2405-2413. Clayton, J. Presentation at Sex-Specific Reporting of Scientific Research: A Workshop. Institute of Medicine, Washington, DC. FDA (U.S. Food and Drug Administration). 2010. Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials. http://www.fda.gov/ downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu ments/UCM071121.pdf (accessed November 14, 2011). Freedman, L. S., R. Simon, M. A. Foulkes, L. Friedman, N. L. Geller, D. J. Gordon, and R. Mowery. 1995. Inclusion of women and minorities in clini- cal trials and the NIH Revitalization Act of 1993—The perspective of NIH clinical trialists. Control Clin Trials 16(5):277-285; discussion 286-289, 293-309. Gandhi, M., N. Ameli, P. Bacchetti, G. B. Sharp, A. L. French, M. Young, S. J. Gange, K. Anastos, S. Holman, A. Levine, and R. M. Greenblatt. 2005. Eli- gibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols. AIDS 19(16):1885-1896. GAO (U.S. General Accounting Office). 1992. Women’s Health: FDA Needs to Ensure More Study of Gender Differences in Prescription Drug Testing. GAO/HRD-93-17. http://archive.gao.gov/d35t11/147861.pdf (accessed No- vember 2, 2011). Gigerenzer, G. 2002. Calculated Risks: How to Know When Numbers Deceive You. New York: Simon & Schuster.

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42 SEX-SPECIFIC REPORTING OF SCIENTIFIC RESEARCH Goldkind, S. F., L. Sahin, and B. Gallauresi. 2010. Enrolling pregnant women in research—lessons from the H1N1 influenza pandemic. N Engl J Med 362(24):2241-2243. Goodman, S. N. 1999. Toward evidence-based medical statistics. 2: The Bayes factor. Ann Intern Med 130(12):1005-1013. Gurwitz, J. H., N. F. Col, and J. Avorn. 1992. The exclusion of the elderly and women from clinical trials in acute myocardial infarction. JAMA 268(11):1417-1422. IOM (Institute of Medicine). 2010. Women’s Health Research: Progress, Pit- falls, and Promise. Washington DC: The National Academies Press. IOM. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: National Academies Press. ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. 1988. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS- 2. Lancet 2(8607):349-360. Jagsi, R., A. R. Motomura, S. Amarnath, A. Jankovic, N. Sheets, and P. A. Ubel. 2009. Under-representation of women in high-impact published clinical cancer research. Cancer 115(14):3293-3301. Kahn, S. E., B. Zinman, J. M. Lachin, S. M. Haffner, W. H. Herman, R. R. Holman, B. G. Kravitz, D. Yu, M. A. Heise, R. P. Aftring, and G. Viberti. 2008. Rosiglitazone-associated fractures in type 2 diabetes: An analysis from A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care 31(5):845-851. Kent, D., and R. Hayward. 2007a. When averages hide individual differences in clinical trials. American Scientist 95(1):60-68. Kent, D. M., and R. A. Hayward. 2007b. Limitations of applying summary re- sults of clinical trials to individual patients: The need for risk stratification. JAMA 298(10):1209-1212. Kim, E. S., and V. Menon. 2009. Status of women in cardiovascular clinical trials. Arterioscler Thromb Vasc Biol 29(3):279-283. Mittelstrass, K., J. S. Ried, Z. Yu, J. Krumsiek, C. Gieger, C. Prehn, W. Roemisch-Margl, A. Polonikov, A. Peters, F. J. Theis, T. Meitinger, F. Kronenberg, S. Weidinger, H. E. Wichmann, K. Suhre, R. Wang-Sattler, J. Adamski, and T. Illig. 2011. Discovery of sexual dimorphisms in metabolic and genetic biomarkers. PLoS Genet 7(8):e1002215. NIH (National Institutes of Health). 2011. Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research: Comprehensive Report: Tracking of Human Subjects Research As Reported in Fiscal Year 2009 and Fiscal Year 2010. Washington, DC: HHS and NIH. Putting gender on the agenda. 2010. Nature 465(7299):665. Sleight, P. 2000. Debate: Subgroup analyses in clinical trials: Fun to look at— but don’t believe them! Curr Control Trials Cardiovasc Med 1(1):25-27.

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WORKSHOP SUMMARY 43 Wald, C., and C. Wu. 2010. Biomedical research. Of mice and women: The bias in animal models. Science 327(5973):1571-1572. Wong, J. B. 2011. What are my chances? Presentation at Sex-Specific Reporting of Scientific Research: A Workshop. Institute of Medicine, Washington, DC. Zucker, I., and A. K. Beery. 2010. Males still dominate animal studies. Nature 465(7299):690.

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