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Health Canada should be applauded for becoming a world leader in the proactive release of clinical study reports and trial protocols from submissions to support market authorization of drugs and medical devices(1). However, these valuable documents will only have an impact to the extent that they are used. Given the well-documented biases that pervade the medical literature(2,3), it is incumbent upon reviewers, developers of clinical practice guidelines, drug formulary decision makers, educators, and others who evaluate drugs and devices to ensure that they utilize clinical study reports and other documents now available through Health Canada.
To further improve transparency, we urge Health Canada to release their reviewer reports on product submissions, showing their interpretations of the data, including any gaps, plans to address these, and the basis for their decisions. The current explanation about data interpretation in the Summary Basis of Decision documents is too brief and inconsistent in terms of how much information is conveyed(4). As well, we call on Health Canada to establish a framework for releasing de-identified individual patient-level data, as others have done(5), to allow for full reanalysis and secondary analyses by independent researchers.
The impact of increased transparency and independent evaluations of drugs and devices will be a more accurate understanding by clinicians of the benefits and harms of our interventions, to the benefi...
Show MoreCompeting Interests: JL reports receiving consulting fees from Michael F. Smith, Lawyer, and Goodmans LLP. He has also received payment for being part of panels for the American Diabetes Association and Canadian Institutes of Health Research, and speaker fees from Toronto Reference Library. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. EAJ has no competing interests to declare.References
- 1. Egilman AC, Ross JS, Herder M. Optimizing the data available via Health Canada’s clinical information portal. CMAJ. 2021 Aug 23;193(33):E1305–6.
- 2. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008 Jan 17;358(3):252–60.
- 3. Seife C. Research Misconduct Identified by the US Food and Drug Administration: Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature. JAMA Intern Med. 2015 Apr 1;175(4):567–77.
- 4. Habibi R, Lexchin J. Quality and Quantity of Information in Summary Basis of Decision Documents Issued by Health Canada. PLOS ONE. 2014 Mar 20;9(3):e92038.
- 5. Vazquez E, Gouraud H, Naudet F, Gross CP, Krumholz HM, Ross JS, et al. Characteristics of available studies and dissemination of research using major clinical data sharing platforms. Clin Trials Lond Engl. 2021 Aug 18;17407745211038524.