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Invited Commentary
November 2018

Studying Drug Safety in the Real World

Author Affiliations
  • 1Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
  • 2Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada
  • 3Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada
  • 4Sunnybrook Research Institute, Toronto, Ontario, Canada
JAMA Intern Med. 2018;178(11):1533-1534. doi:10.1001/jamainternmed.2018.5766

Drugs are typically brought to market based on the results of randomized clinical trials (RCTs). In their simplest construction, 1 group of patients receives the new drug while another receives something else—usually placebo or another therapy. If the 2 groups of patients are similar at baseline, any differences in outcome (positive or negative) can be reasonably attributed to the drug being tested. The appeal of RCTs rests in their simplicity, and avoidance of biases and confounding. Randomized clinical trials are generally the best way to establish the risks and benefits of a therapeutic intervention for a particular group of patients.

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    1 Comment for this article
    Do Specialty Societies Always Choose Wisely?
    Matthew Hodge, MDCM, PhD | University of Toronto
    Zipursky & Juurlink's well-reasoned commentary is curiously silent on a potential implication of the work by Bouck et al., namely that specialty-focused professional organizations are not best-positioned to choose wisely...nephrologists do not care for the tsunami of patients with musculoskeletal complaints seen in primary care settings who are seeking relief from their pain. Patient-focused wise choices require risk management, just like daily life.

    The work of Bouck et al. in providing substantial evidence regarding the safety of NSAIDs prescribed in primary care also suggests that one group's wise choices may simply be organ system turf defence. Are we not
    overdue for conversations and practice guidance rooted in the real experiences and outcomes of real people?