Enrollment of Women in Cardiovascular Trials Fails to Meet Current Federa...( Cleveland Clinic Researchers Hig...),Health

Cleveland Clinic Researchers Highlight the Need For More Women to

Participate in Clinical Trials

ORLANDO, Fla., Nov. 6 /PRNewswire-USNewswire/ -- 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 (http://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.

"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 dese
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