FROM PROTECTIONISM TO ACCESS: WOMEN & PARTICIPATION IN CLINICAL TRIALS - CONFLICT, CONTROVERSY, AND CHANGE

Abstract

There is a general perception that biomedical research has not given the same attention to the health problems of women that it has given to those of men, and that women may not have benefited from advances in medical diagnosis and therapy because of their lower rates of participation in clinical studies. This paper explores the historical exclusion of women of childbearing potential from clinical trials and the changes in policy and regulations that have occurred. The recent shift from protectionist policies toward policies of access and inclusion remains controversial. Arguments and rationales for and against including women in clinical trials are described, and the empirical evidence of women’s participation in these trials is analyzed. It appears that the current regulatory system, supported by federal policy, promotes the inclusion of women in clinical trials, and the results of empirical studies indicate that women are in fact being included. The benefits of inclusion, balanced against the increased cost of including women, reveal that the added cost of inclusion and subgroup differences analysis may jeopardize the long-term goals of improving scientific knowledge and understanding the health problems of all peoples. Alternatives to clinical trials are discussed as a means of producing similar information at lower cost. The paper concludes with a brief discussion of the need to change the popular perception that women are being neglected by clinical research to their detriment, rather than changing the existing policy and regulatory system regarding their inclusion in clinical trials.