Alert System Increases Clinical Trial Recruitment
An electronic health record-based clinical trial alert system increased recruitment rates and clinicians' 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 clinicians 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 his colleagues determined whether a clinical trial alert (CTA) system could increase clinicians' participation in the recruitment of patients to a clinical trial. After one year of traditional recruitment to a clinical trial, the scientists 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 clinician about the ongoing trial.
The scientists found that the CTA intervention was associated with a 10-fold increase in the number of referrals generated by clinicians, 5.7 per month before intervention to 59.5 per month after. The number of clinicians 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 clinicians received at least one CTA. Of the 48 clinicians 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 clinicians' 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."
(Arch Intern Med. 2005;165:2272-2277. Available pre-embargo to the media at www.jamamedia.org).