Women's College Research Institute

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Cardiac clinic trials need to include more real world patients

October 2014

Dr. Jay UdellA new study led by Dr. Jay Udell, a cardiologist at Women’s College Hospital and scientist at Women’s College Research Institute, found that clinical trials with heart attack patients need to include a broader range of individuals typically seen by doctors.

Udell led an analysis of the largest ongoing observational study of U.S. heart attack patients and found that trial participants had a lower risk of dying and a more favourable prognosis compared with the broader population. These findings, published in the Journal of the American Medical Association, are concerning because they raise questions about whether trial findings can be generalized to the wider population.

“The participants were younger and healthier, and were more likely to receive testing and treatment than those who didn’t participate,” says Udell. “These individuals reflect a small portion of the typical patients we see in offices and hospitals, and we are missing a large number of potentially eligible patients from our clinical trials who are right at our fingertips.”

Clinical trials are the gold standard for testing new therapies and treatments for disease, and doctors often rely on the results of these studies to treat their patients; therefore, it’s important that patients participating in these trials reflect the patients seen in routine practice.

“By making a greater effort to broaden clinical trial enrolment criteria and use patients already listed in national and provincial patient registries, we can get more patients to participate and enhance the generalizability of our results,” says Udell. “And that way, doctors can be more confident that the care they provide is as effective and safe as that demonstrated in the original clinical trial.”

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