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Older Women Often Excluded From Clinical Research: Age Bias or Gender Bias?

Jocalyn P. Clark, MSc

A recent article published in a special issue of the Canadian Medical Association Journal on Diversity and Women's Health described poor inclusion and representation of women in clinical drug trials for treatment of myocardial infarction (MI). Despite heart disease being a leading cause of disability and death among North American women, especially older women, less than one-quarter of the patients included in the studies were women and the average age of participants was only 62 years. The work of Rochon and colleagues at the University of Toronto extends earlier findings of Gurwitz et al. at the University of Massachusetts who reviewed the literature for a 30 year period up to 1991 and found that women represented only 20% of MI drug trial participants. Most of these trials excluded patients over the age of 75 years. Traditionally, older people have been poorly represented in clinical trials because they are more difficult to study: they tend to have coexisting illnesses, they use other medications that may interact with study drugs, and the elderly are more vulnerable to adverse drug effects. Additional reasons for explaining women's exclusion include fear of harming a fetus, hormonal fluctuations that may complicate responses to medication, and the use of estrogens which may be protective for some diseases.