CardioExchange Archive

The days of passively recruiting for outpatient clinical trials by having a research coordinator in a clinic manually review charts to determine which patients are eligible will soon be over. How soon is hard to tell, but institutions like Geisinger Medical Center in Pennsylvania, where I am Director of the Center for Clinical Studies (and an interventional cardiologist), have already demonstrated a much more efficient approach, as recently highlighted in the Wall Street Journal.

Because of its longstanding use of electronic medical records (about 13 years now) and its stable patient population, Geisinger is able to programmatically identify large numbers of patients with chronic conditions who meet the eligibility requirements for a given clinical trial, whether in orthopedics or vascular disease, endocrinology or neurology, etc. And because patients in north central Pennsylvania are so beneficent, large percentages respond favorably to letters from their healthcare providers inviting them to learn more about trials for which they appear to qualify. As a result, when it comes to trials targeting outpatients with ongoing or chronic conditions, Geisinger can enroll more individuals than any other institution I’ve ever heard of.

Our approach to recruitment is clearly in the best interests of the study sponsors: it can reduce the number of sites needed for a given trial, speed the completion of the trial, reduce the overall costs associated with the trial, and, ultimately, help bring a drug to market more rapidly. Yet commercial research organizations (CROs) and, at times, sponsors themselves have been reluctant to reimburse us for the upfront, “atypical” costs associated with our approach — for example, EMR programming, letter mailing campaigns, and a call center.

Why the hesitation? CROs use a “one size fits all” paradigm for reimbursement (in which all sites are paid per enrolled patient and generally reimbursed the same amounts), and they are resistant to treating sites differently from one another, even those as unique as Geisinger. Furthermore, even though our approach serves the best interests of the sponsors, it may not do the same for CROs.

So, now the question arises: Are the interests of CROs and sponsors truly so aligned? Can CROs, pharma, and other study sponsors be flexible enough to take advantage of the power of the EMR to transform recruiting for clinical trials?