Clinical Trials
Electronic health record-based clinical trial alert system increased recruitment rates
Oct 25, 2005 - 5:15:38 AM

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 the 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."

In an accompanying editorial, Al B. Benson III, M.D., from Northwestern University, Feinberg School of Medicine, Chicago, discusses the clinical trial research process.

"Even under the most optimal circumstances, obstacles confront most clinical research projects that can delay the reporting of important clinical information. …Because important obstacles to the successful maintenance of a given clinical trials program include recruitment strategies, costs, and time commitments, the integration of an institution's electronic records system with the research record could help to reduce some of the barriers to the accrual of patients to clinical trials," Dr. Benson writes.

"Our country must weigh the risks vs. benefits of clinical research for current and future generations, as well as the costs, training of health care personnel, donation of human biological specimens for research purposes, regulatory and ethical requirements, and the commitment to actively participate in research trials in far greater numbers. …For our clinical research enterprise to thrive and to better promote evidence-based medicine, the public and leaders in medicine, industry, and government must have the will to find the way to guarantee sustainable medical advances."

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