Revealing unpublished drug data

The best doctors, clinics and hospitals rely on published clinical trial data to inform their prescribing and treatment recommendations. But what if the data are flawed?

“Clinical trial data fuel clinical decisions,” says Dr. An-Wen Chan. “But data that aren’t exciting, or that show a drug to be ineffective or unsafe, are often left unpublished.”

The result is that less than half of clinical trial data are ever published, leaving researchers and doctors with only a tiny glimpse of how a drug really performs. Based on this skewed perspective, doctors may not be giving their patients the best treatment. This skew often impacts women and older people the most, since these groups are generally under-represented in clinical trials.

“What it means is that even doctors who do their due diligence and review the studies are still missing the whole story,” says Chan.

Treatments that don’t work are more than a waste of time. They cause stress, cost money, and can be potentially harmful. In fact, eight out of 10 prescription drugs pulled from the U.S. market from 1997 to 2001 were removed because they were found to cause more side effects in women than the clinical trials had initially indicated. In addition, patients whose symptoms linger or progress often end up booking more appointments, driving up systemic costs.

That’s why Chan has written a how-to guide – published in a special report of the British Medical Journal – that helps scientists capture easy-to-miss unpublished data in their systematic reviews. He is also leading the international SPIRIT* initiative to define standards for clinical trial protocols, which will make trial methodologies more transparent.

“Ultimately, my work translates into better safety for patients enrolled in trials, and more robust evaluation of the study data,” says Chan.

“And when doctors and policymakers can see all the information on a drug or therapy, it means better outcomes for all patients.”

*SPIRIT is funded by the Canadian Institutes of Health Research, the National Cancer Institute of Canada and the Canadian Agency for Drugs and Technologies in Health.

Dr. An-Wen Chan is a Rhodes Scholar and Phelan Scientist at WCRI who is having international impact by advancing the creation of guidelines to improve the transparency of clinical trials and research. He is a dermatologist at Women’s College Hospital and one of Ontario’s few experts in Mohs surgery. Chan is also a University of Toronto assistant professor in the Division of Dermatology and the Institute of Health Policy, Management and Evaluation.