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November 2005 Issue

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New System May Drive Clinical Trial Recruiting

Published November 2005

Across the country, clinician-researchers face a constant battle: getting people to enroll in clinical trials.

Fliers line hallways and fill bulletin boards, and advertisements flank the pages of local papers, but some trials still go unfilled.

One of the most effective forms of clinical trial recruitment, researchers agree, is obtaining the support of other physicians.

Studies have shown that physician participation increases both the chance that eligible patients will be referred for clinical trials and the likelihood that suggested subjects will participate.

But demands in the clinical setting provide limited opportunity for this type of physician-patient interaction.

Now new research led by Peter Embi, MD, assistant professor of medicine and researcher at UC's Institute for the Study of Health, suggests that by capitalizing on electronic medical record technology, it may be possible to increase both clinical trial enrollment and physician referrals.

Dr. Embi and a team of researchers used electronic medical record system tools in a new way to alert physicians when their patients were eligible for clinical trials. They found that this Clinical Trial Alert (CTA) system could be just the ticket for increasing enrollment.

The findings were published in the Oct. 24, 2005, edition of the Archives of Internal Medicine.

"The success of clinical trials depends on the timely recruitment of enough eligible subjects," says Dr. Embi. "Researchers spend a lot of time and effort trying to find subjects for their studies, but most traditional recruitment methods aren't very effective.

"We wanted to find another way to increase study recruitment, using technology that will soon make its way into many outpatient clinics."

Dr. Embi and his team carefully monitored a full year of traditional recruitment (fliers, word of mouth and memorandums) for a trial of patients with type 2 diabetes at the Cleveland Clinic. Then they activated the CTA system in outpatient clinics.

The system works like this: As a physician talks with patients about their medical history and enters information onto their electronic chart, the CTA system scans the information for key data that match current clinical trials. If a patient meets a critical portion of a trial's eligibility requirements, the CTA sends an alert, like a pop-up, to the patient's electronic medical record screen. The physician can then ask if the patient is interested in participating in the trial. If the patient agrees, the physician simply clicks a button to send a message to the study coordinator, who will take it from there. All of this happens within the secure environment of the electronic medical record.

After the CTA was activated, Dr. Embi's team noticed an eight-fold increase in the number of physicians referring patients to the trial, and 10 times the number of patients actually referred per month. The increase doubled the enrollment of physician-referred patients in the specific diabetes trial they were monitoring.

"It's often difficult during a busy office visit to remember what clinical trials are available for your patient," says Dr. Embi, "much less find the time to determine whether your patient is actually eligible, discuss the trial and then refer them on for possible enrollment.

"The CTA makes the recruitment process easier and can help many more physicians offer their patients the opportunity to participate in a trial."

Michael Privitera, MD, of UC's neurology department, is heading the electronic medical records effort at UC Physicians, a multi-specialty practice made up of more than 500 UC faculty. He sees Dr. Embi's new technology as just one of many benefits of digitizing charts.

"We know that electronic medical records cut down on medical errors and improve quality of care," says Dr. Privitera. "This new technology will match patients who need advanced treatments with our many clinical and translational research experts to bring the most advanced health care possible to our region."

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