Trio of BMJ papers to impact how clinical research is performed

January 9, 2019

pile of scientific journalsPhoto Dave Crosby, Flickr Researchers at The Ottawa Hospital and the University of Ottawa played important roles in three papers recently published in The BMJ (British Medical Journal) that are expected to impact how clinical research is conducted around the world. The first paper answers the crucial question of how to calculate and justify the sample size (number of patients needed) for a given clinical trial. This is important because if too few patients are included, it may be impossible to detect important clinical differences between the groups. But including too many patients raises costs and risks. The second paper provides the first rigorous guidance on an innovative and increasingly popular kind of trial called the stepped-wedge cluster randomized trial. This involves randomizing groups (or clusters) of patients to receive different treatments at different times, rather than randomizing each patient individually. The last paper provides crucial guidance for how to report research that uses routinely-collected data (such as electronic health records) for the study of drug safety and efficacy.

“The Ottawa Hospital is a global leader in developing new and better ways to conduct clinical research,” said Dr. Dean Fergusson, Director of The Ottawa Hospital’s Clinical Epidemiology Program and professor at the University of Ottawa. “This kind of work is improving health and transforming care in Ottawa and around the world.”

Authors affiliated with The Ottawa Hospital: Eric Benchimol, Dean Fergusson, Jeremy Grimshaw, David Moher, Stuart Nicholls, Monica Taljaard.

Core resources: Ottawa Methods Centre

Funding: Research at The Ottawa Hospital is possible because of generous support for The Ottawa Hospital Foundation. This research was also supported by MRC-NIHR UK, the University of Aberdeen, the Scottish Government Health and Social Care Directorates, the Australian National Health and Medical Research Council, the Welcome Trust, the Canada Research Chairs Program, the International Society for Pharmacoepidemiology, the Canadian Institutes of Health Research, the Canadian Association of Gastroenterology, Crohn’s and Colitis Canada, Canadian Child Health, Fonds de recherche du Québec—Santé and the Programme for Clinical Research Infrastructure.

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