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New technology could improve clinical trial recruitment

October 25, 2005

CINCINNATI-Electronic medical records are touted as a great way to prevent medical errors, but researchers are reporting that this new technology may also be just what the doctor ordered for clinical trial recruitment.

A new study led by Peter Embi, MD, assistant professor of medicine at the University of Cincinnati (UC) and researcher at UC's Institute for the Study of Health, shows that by using the tools of an electronic medical record system in a new way, it's possible to increase the number of patients who volunteer to participate in clinical studies and generate more referrals from the physician community.

The research, conducted in large part at the Cleveland Clinic, appears 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," said 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."

Even in fields like oncology, where clinical trial enrollment for all eligible patients is considered the goal, as few as 2 percent of patients participate, the report says.

"We wanted to find another way to increase study recruitment across the board, using technology that will soon make its way into many outpatient clinics," said Dr. Embi.

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 end of the year, they activated what they call a Clinical Trial Alert (CTA) system.

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. This increase resulted in a doubling of the study enrollment rate from physician referrals for the specific diabetes trial they were monitoring.

The CTA system works by scanning the information a physician keys into a patient's electronic chart. As the physician talks with patients about their medical history and enters information, the CTA system searches for key data that match up with current clinical trials.

If a patient matches a critical portion of a trial's eligibility requirements, the CTA sends an alert-like a pop-up-to the screen of the patient's electronic medical record.

The physician is reminded about the study and can then ask if the patient is interested in being considered for it. 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.

"It's often difficult during a busy office visit to remember what clinical trials are available for your patient, much less find the time to determine whether your patient is actually eligible, discuss the trial and then refer the patient on for possible enrollment," said Dr. Embi. "By leveraging the electronic medical record's capabilities, the CTA made the recruitment process easier and helped many more physicians offer their patients the opportunity to participate in the trial."

Dr. Embi plans to continue research on the CTA system and clinical trial recruitment at the University of Cincinnati and UC Physicians, a multi-specialty practice made up of over 500 University of Cincinnati faculty.

Additional authors include Richard Hornung, DrPH, University of Cincinnati, and Anil Jain, MD, Jeffrey Clark, Susan Bizjack and C. Martin Harris, MD, all of the Cleveland Clinic Foundation.

University of Cincinnati