May 13, 2011

Translating Clinical Trials into the Real World

(Ivanhoe Newswire) -- Physicians are struggling to translate clinical research into everyday practice. A new study shows that medical therapy from a widely publicized clinical trial was applied less than half the time to heart stent patients.

Researchers from NewYork-Presbyterian Hospital/Weill Cornell Medical Center reviewed almost 500,000 cardiac cases across the country. They found that medical therapy given to patients who received a heart stent improved less than three percent as a result of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial. Less than half of all patients received appropriate treatment with the combination of common cardiac drugs used in the trial, such as aspirin, before their stenting procedure, and nearly one-third didn't receive these drugs afterward.

The research team, included investigators from the University of California at San Francisco, Duke Clinical Research Institute, and the University of Missouri.  Researchers wanted to see if heart care changed after publication of the $33.5 million COURAGE clinical trial.

"We find that an expensive and highly publicized clinical trial had a very limited effect on the clinical practice of providing optimal medical therapy, and this snapshot of what is happening in the real world should be a call for physicians, as well as policymakers, to look at how patient care can be improved," the study's lead author, William Borden, M.D., cardiologist, and assistant professor of medicine and of public health and the Nanette Laitman Clinical Scholar in Public Health at Weill Cornell Medical College, quoted as saying.

In the COURAGE trial, more than 2,000 patients with stable coronary artery disease received either "optimal medical therapy" alone or the same therapy along with a stent. Researchers say the wide publicity that followed publication of the study resulted in a net benefit of 1.2 percent increase in use of optimal medical therapy before a stent was inserted, and 2.5 percent after the procedure.

"I was surprised," Dr. Borden was quoted as saying. "I thought there would be more of an improvement in medical therapy over time, but we have seen this difficulty in translating clinical trial evidence into practice before."

Researchers say physicians and other health care workers may not be working together as part of a team, and that's a possible reason for this failure. Researchers say there should be a shared responsibility among all physicians, including the primary care doctor and general cardiologist, in caring for the patients, in order to improve care.

Source: JAMA, May 10, 2011