Enrollment Of Women In Cardiovascular Trials Fails To Meet Federal Mandates

Armen Hareyan's picture
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Cleveland Clinic researchers have recently found that women remain a significant minority in cardiovascular randomized controlled trials funded by the National Heart, Lung and Blood Institute (NHLBI).

Lead Author, Esther S.H. Kim, M.D., M.P.H., Senior Author Venu Menon, M.D., and a team of Cleveland Clinic researchers searched the National Institutes of Health's (NIH) database of clinical trials (www.clinicaltrials.gov) for studies funded by the NHLBI with outcomes of stroke, heart attack, or death. The studies were published between 1997 and 2006.

Results of "Enrollment of Women in NHLBI Funded Cardiovascular Randomized Controlled Trials Fail to Meet Current Federal Mandates for Equal Inclusion" were presented at the American Heart Association's 27th Annual Scientific Session currently underway in Orlando, Fla.

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"Despite federal mandates, NIH policies, and ongoing NIH scrutiny, enrollment of women remains inadequate in NIH-sponsored, phase III-IV, cardiovascular randomized, controlled trials," Dr. Kim said. "In addition, there has been little change in the proportion of women enrolled in these trials over the past decade."

This under-representation of women subjects was recognized over a decade ago and resulted in a NIH mandate for the inclusion of women in clinical research. Cleveland Clinic researchers sought to evaluate the impact of these guidelines on federally funded cardiovascular randomized controlled trials.

Women account for half the cardiovascular mortality in the United States, but it is unknown why more women do not sign up for these clinical trials. Increased participation of women in acute and high-risk cardiovascular, randomized, controlled trials remains a priority and deserves ongoing scrutiny, Dr. Kim said.

She suggests that educational efforts at the level of the patient, study site, and investigator are needed to increase participation of women. Additional research into why so few women participate in clinical trials is also warranted, she said.

Of the 982 NHLBI-funded cardiovascular studies examined, 141 were phase III or IV randomized controlled trials in adults, 53 had outcomes of interest, and only 19 were published between 1997 and 2006. The research spanned 19 trials: nine acute, eight high risk, eight coronary artery disease, three congestive heart failure and seven electrophysiology trials, in addition to one hypertension trial. Researchers observed no increase in the enrollment of women between 1997 and 2006 (mean 27%, range 10-47%). There was no association between enrollment and acuity, type of disease, or level of risk.

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