Disadvantaged, outnumbered, and discouraged: women’s experiences as healthy volunteers in U.S. Phase I trials

References

• Abadie, R. (2010). The professional guinea pig: Big pharma and the risky world of human subjects. Durham, NC: Duke University Press.
   Google Scholar
• Bennett, J. C. (1993). Inclusion of women in clinical trials–Policies for population subgroups. New England Journal of Medicine, 329(4), 288–292.
   PubMed Web of Science ®Google Scholar
• Bren, L. (2005). Does sex make a difference? FDA Consumer Magazine, 39(4), 10–15.
   Google Scholar
• Carpenter, D. (2010). Reputation and power: Organizational image and pharmaceutical regulation at the FDA. Princeton, NJ: Princeton University Press.
   Google Scholar
• Chen, A., Wright, H., Itana, H., Elahi, M., Igun, A., Soon, G., … Fadiran, E. O. (2018). Representation of women and minorities in clinical trials for new molecular entities and original therapeutic biologics approved by FDA CDER from 2013 to 2015. Journal of Women’s Health, 27(4), 418–429.
   PubMed Web of Science ®Google Scholar
• Corbie-Smith, G., Thomas, S. B., Williams, M. V., & Moody-Ayers, S. (1999). Attitudes and beliefs of African Americans toward participation in medical research. Journal of General Internal Medicine, 14, 537–546.
   PubMed Web of Science ®Google Scholar
• Corrigan, O. P. (2002). “First in man”: The politics and ethics of women in clinical drug trials. Feminist Review, 72, 40–52.
   Google Scholar
• Cottingham, M. D., & Fisher, J. A. (2016). Risk and emotion among healthy volunteers in clinical trials. Social Psychology Quarterly, 79(3), 222–242.
   PubMed Web of Science ®Google Scholar
• DiMasi, J. A., Feldman, L., Seckler, A., & Wilson, A. (2010). Trends in risks associated with new drug development: Success rates for investigational drugs. Clinical Pharmacology and Therapeutics, 87(3), 272–277.
   PubMed Web of Science ®Google Scholar
• Edelblute, H. B., & Fisher, J. A. (2015). Using “clinical trial diaries” to track patterns of participation for serial healthy volunteers in U.S. phase I studies. Journal of Empirical Research on Human Research Ethics, 10(1), 65–75.
   PubMed Web of Science ®Google Scholar
• Epstein, S. (2007). Inclusion: The politics of difference in medical research. Chicago, IL: University of Chicago Press.
   Google Scholar
• Fisher, J. A. (2015a). Stopped hearts, amputated toes, and NASA: Contemporary legends among healthy volunteers in US phase I clinical trials. Sociology of Health and Illness, 37(1), 127–142.
   PubMed Web of Science ®Google Scholar
• Fisher, J. A. (2015b). Feeding and bleeding: The institutional banalization of risk to healthy volunteers in phase I pharmaceutical clinical trials. Science, Technology, & Human Values, 40(2), 199–226.
   PubMed Web of Science ®Google Scholar
• Fisher, J. A., & Kalbaugh, C. A. (2011). Challenging assumptions about minority participation in U.S. clinical research. American Journal of Public Health, 101(12), 2217–2222.
   PubMed Web of Science ®Google Scholar
• Fisher, J. A., McManus, L., Wood, M. M., Cottingham, M. D., Kalbaugh, J. M., Monahan, T., & Walker, R. L. (in Press). Healthy volunteers’ perceptions of the benefits of their participation in phase I clinical trials. Journal of Empirical Research on Human Research Ethics.
   Web of Science ®Google Scholar
• Fisher, J. A., & Ronald, L. M. (2010). Sex, gender, and pharmaceutical politics: From drug development to marketing. Gender Medicine, 7(4), 357–370.
   PubMedGoogle Scholar
• George, S., Duran, N., & Norris, K. (2014). A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders. American Journal of Public Health, 104(2), E16–E31.
   PubMed Web of Science ®Google Scholar
• Holdcroft, A. (2007). Gender bias in research: How does it affect evidence based medicine? Journal of the Royal Society of Medicine, 100(1), 2–3.
   PubMed Web of Science ®Google Scholar
• Mazure, C. M., & Jones, D. P. (2015). Twenty years and still counting: Including women as participants and studying sex and gender in biomedical research. BMC Women’s Health, 15(1), 94.
   PubMed Web of Science ®Google Scholar
• McGregor, A. J., Barr, H., Greenberg, M. R., Safdar, B., Wildgoose, P., Wright, D. W., & Hollander, J. E. (2014). Gender‐specific regulatory challenges to product approval: A panel discussion. Academic Emergency Medicine, 21(12), 1334–1338.
   PubMed Web of Science ®Google Scholar
• Meibohm, B., Beierle, I., & Derendorf, H. (2002). How important are gender differences in pharmacokinetics? Clinical Pharmacokinetics, 41(5), 329–342.
   PubMed Web of Science ®Google Scholar
• Merton, V. (1994). The exclusion of pregnant, pregnable, and once-pregnable people (A.K.A. Women) from biomedical research. Texas Journal of Women and the Law, 3, 307–402.
   Google Scholar
• Miller, M. A. (2001). Gender-based differences in the toxicity of pharmaceuticals: The Food and Drug Administration’s perspective. International Journal of Toxicology, 20(3), 149–152.
   PubMed Web of Science ®Google Scholar
• NIH Office of Research on Women’s Health. (n.d.). Report of the NIH Advisory Committee on Research on Women's Health. Bethesda, MD: U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health.
   Google Scholar
• Parekh, A. (2010). Women in clinical trials: FDA policies. Paper presented at the IOM Forum on Neuroscience and Nervous System Disorders, San Francisco, CA.
   Google Scholar
• Patton, M. Q. (2002). Qualitative research and evaluation methods (3rd ed. ed.). Thousand Oaks, CA: Sage Publications.
   Google Scholar
• Pinnow, E., Sharma, P., Parekh, A., Gevorkian, N., & Uhl, K. (2009). Increasing participation of women in early phase clinical trials approved by the FDA. Women’s Health Issues, 19, 89–93.
   PubMed Web of Science ®Google Scholar
• Rogers, W. A. (2006). Feminism and public health ethics. Journal of Medical Ethics, 32(6), 351–354.
   PubMed Web of Science ®Google Scholar
• Seear, K. (2014). The makings of a modern epidemic: Endometriosis, gender, and politics. Surrey, England: Ashgate.
   Google Scholar
• U.S. General Accounting Office (GAO). (2001). Drug safety: Most drugs withdrawn in recent years had greater health risks for women (GAO-01-286R). Washington, D.C.: U.S. General Accounting Office. Retrieved from http://www.gao.gov/new.items/d01286r.pdf
   Google Scholar
• Waggoner, M. R. (2013). Motherhood preconceived: The emergence of the preconception health and health care initiative. Journal of Health Politics, Policy and Law, 38(2), 345–371.
   PubMed Web of Science ®Google Scholar
• Weiss, R. S. (1994). Learning from strangers: The art and method of qualitative interview studies. New York: Free Press.
   Google Scholar