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Enrollment of Women in Cardiovascular Trials Fails to Meet Current Federal Mandates
Date:11/6/2007

rves 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.

Cleveland Clinic, located in Cleveland, Ohio, is a not-for-profit multispecialty academic medical center that integrates clinical and hospital care with research and education. Cleveland Clinic was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Approximately 1,800 full-time salaried physicians and researchers at Cleveland Clinic and Cleveland Clinic Florida represent more than 100 medical specialties and subspecialties. In 2006, there were 3.1 million outpatient visits to Cleveland Clinic. Patients came for treatment from every state and from more than 80 countries. There were more than 53,000 hospital admissions to Cleveland Clinic in 2006. Cleveland Clinic's Web site address is http://www.clevelandclinic.org.


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