ATLANTA -- After reviewing the data from four of the largest multi-center randomized clinical trials of new heart disease drugs, Duke University Medical Center researchers have found significant differences in heart attack rates reported by physicians who actually provide the patient care and the physician committees responsible for later determining whether a heart attack actually occurred.

The Duke researchers said these differences, which occurred in up to one-fifth of the cases, increased the perceived benefits of the drug being tested in one trial and decreased the perceived benefits of the drug in the other three trials. While these differences of opinion had no effect on patient care, the researchers believe that the results should help them refine the way future trials are designed and carried out.

Most large clinical trials use clinical events committees (CEC) to review case records to ensure that all the physicians at participating hospitals follow the same guidelines. CECs are usually composed of cardiology fellows and attending cardiologists and their rulings are final.

Differences of opinion have become common as large multi-center trials use more subtle measurements, or endpoints, to determine the effectiveness of a particular treatment.

"It is very important for us involved in clinical trial design to understand why such significant differences between the physicians and the committees exist, and to make changes," said Duke cardiologist Dr. Kenneth Mahaffey. "Because physicians treat their patients differently from hospital to hospital, and from country to country in clinical trials, we need to have a systematic way of reporting heart attacks in these patients."

In the 1980s, death was a common measurement for clinical trials, an endpoint that leaves no room for disagreement among physicians, the researchers said.

"However, in the 1990s, we started using
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Contact: Richard Merritt
Merri006@mc.duke.edu
919-684-4148
Duke University Medical Center
31-Mar-1998