Disagreements Between Clinical Trial Oversight Committees And Physicians Can Affect Drug Trial Results

such endpoints as recurrent infarction (heart attack) to determine whether or not a drug was effective," Mahaffey said. "While most cases of reinfarction are obvious, in up to about 20 percent of the cases, there were differences of opinion whether or not reinfarction actually occurred in the clinical trials, which is similar to what physicians see every day in practice."

Mahaffey prepared the results of the Duke study for presentation Tuesday at the 47th annual scientific session of the American College of Cardiology.

The four trials reviewed by the Duke researchers were called EPIC, IMPACT-II, GUSTO-IIb and PURSUIT. Researchers from the Cleveland Clinic coordinated the EPIC trial, the other three were coordinated by the Duke Clinical Research Institute, of which Mahaffey is a member.

In the EPIC trial, for example, physicians in the field reported that 9 percent of their patients has suffered a reinfarction, but upon further review by the CEC, the rate turned out to be 8.3 percent. For the other three trials, the effect was reversed:

  • IMPACT-II: Physicians reported 5.5 percent rate; the CEC 9.2 percent.

  • GUSTO-IIb: Physicians reported 8.4 percent; the CEC 8.9 percent

  • PURSUIT: Physicians reported 8 percent; the CEC 14.2 percent.

As an example of how disagreements could occur, Mahaffey cited the case of a patient who is rushed to an emergency room with a heart attack and is enrolled in a trial. A few hours later, the patient experiences some chest pain with some EKG and blood enzyme changes.

"Did that patient have another heart attack? Not all cardiologists would agree," Mahaffey said. "So we must come up with ways we formulate our definitions to ensure that everyone is following the same guidelines. We're now looking at changes that can be applied worldwide in the trials we're now designing."

While the outc

Contact: Richard Merritt
Duke University Medical Center

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