Enrollment of Women in Cardiovascular Trials Fails to Meet Current Federa...(rves ongoing scrutiny Dr. Kim said. S...),Health

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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