Importance of and Barriers to Including Women in Clinical Trials
The last decade of the 20th century brought with it an explosion of new genetic information, making it increasingly obvious that many physiologic and pathologic functions are influenced either directly or indirectly by sex-based differences in biology. The scientific community has begun to realize the significance of chromosomal sex to the social and biologic sciences. Current statistics show that one in eight women will develop breast cancer, while one in two women will develop heart disease. Yet, even given these statistics, research regarding therapy and prevention of heart disease has largely been performed in the middle-aged men. Once recognized, the enormous implications of women's historical exclusion from clinical trials quickly became apparent. The medical community just did not know if the treatments proven safe and effective for men could be applied to women without modification. There have been several barriers to research on women including lack of recognition of sex as a factor that could affect health and illness, exclusion of women of childbearing potential, difficulties in recruiting and retaining women as research subjects, complexity of underlying hormonal and reproductive issues in women, and greater drug intolerance in women. © 2004 Elsevier Inc. All rights reserved.
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