Alert system associated with increased clinical trial recruitment

10/20/05

CHICAGO An electronic health record-based clinical trial alert system increased recruitment rates and physicians' participation in an ongoing clinical trial, according to a study in the October 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

The success of clinical trials, critical to the advancement of medical science, depends on the recruitment of enough eligible participants in a timely manner, according to background information in the article. Unfortunately, achieving recruitment goals is difficult and failing to meet these goals can hamper the development and evaluation of new therapies and can increase health care system costs. When treating physicians identify and recruit potentially eligible participants for clinical trials, the likelihood that a given patient will participate in a trial increases.

Peter J. Embi, M.D., M.S., from the University of Cincinnati College of Medicine, and colleagues determined whether a clinical trial alert (CTA) system could increase physicians' participation in the recruitment of patients to a clinical trial. After one year of traditional recruitment to a clinical trial, the researchers used their electronic health record (EHR)-based CTA system at The Cleveland Clinic. When a patient's records met selected trial criteria, the CTA alerted the physician about the ongoing trial.

The researchers found that the CTA intervention was associated with a 10-fold increase in the number of referrals generated by physicians, 5.7 per month before intervention to 59.5 per month after. The number of physicians making referrals also increased, from five before intervention to 42 after. The clinical trial enrollment rate more than doubled from 2.9 participants per month to 6.0 participants per month. During the four-month intervention, all of the 114 participating physicians received at least one CTA. Of the 48 physicians who participated, 42 (88 percent) referred at least one patient to the trial coordinator, and 11 (23 percent) of them generated at least one enrollment.

"Use of an EHR-based CTA led to significant increases in physicians' participation in and recruitment rates to an ongoing clinical trial," the authors write. "Given the trend toward the EHR implementation in health care centers engaged in clinical research, this approach may represent a much-needed solution to the common problem of inadequate trial recruitment."

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