Women, Elderly Not Adequately Represented in Heart Trials
Despite a higher heart disease risk among women and the elderly and government efforts to increase their participation in clinical trials, "neither group has experienced substantial gains in representation" in published cardiovascular studies, a report published in today's Journal of the American Medical Association found. According to the study, the FDA and NIH issued guidelines in the late 1980s and early 1990s to increase participation of women and the elderly -- groups "historically underenrolled" in clinical trials -- in research efforts. In the study, researchers at Duke University Medical Center examined 593 randomized controlled trials of acute coronary syndromes published between January 1966 and March 2000 to determine the "degree to which growing public and governmental awareness of sex and age biases altered" enrollment in cardiovascular clinical trials. The study found that between 1966 and 1990, individuals ages 75 and older represented only 2% of patients enrolled in cardiovascular trials, and since 1990, the number of elderly participants in cardiovascular trials has increased by only 9%. In addition, more than half of the cardiovascular studies published between 1996 and 2000 failed to enroll at least one patient age 75 or older. Among women, the percentage enrolled in cardiovascular trials increased from 20% between 1966 and 1990 to 25% between 1991 and 2000. In studies published after 1995, women's participation increased to 29% (Lee et al., JAMA, 8/8). Dr. Eric Peterson, one of the study's authors, said, "The assumption has been that this situation has improved. It has, but only slightly." He added that the "shortcomings have serious consequences for doctors and patients," pointing out that doctors "don't have enough data" to determine whether women and the elderly, who often "fare worse and develop more complications than others after heart attacks," will respond to treatments (Clabby, Raleigh News & Observer, 8/8).