Optimizing the data available via Health Canada's clinical information portal.

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Date: Aug. 23, 2021
From: CMAJ: Canadian Medical Association Journal(Vol. 193, Issue 33)
Publisher: CMA Impact Inc.
Document Type: Article
Length: 1,712 words
Lexile Measure: 1970L

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Through its Public Release of Clinical Information (PRCI) initiative, Health Canada has provided public access to a vast repository of data that have been submitted to support market authorization of drugs and medical devices. (1) These are published on the agency's online portal (https://clinical -information.canada.ca/search/ci-rc), which is free to access, easy to use and contains a rapidly expanding list of medical products for which data are available. (2) It is unlikely that most patients and clinicians will make use of the clinical data and metadata available through Health Canada's portal; therefore, their greatest potential value is in secondary research on regulatory decision-making, development of clinical practice guidelines and assessment of health technologies. Yet, whether the research community, physicians and others will take full advantage of these data remains to be seen.

Since the PRCI launched in March 2019, Health Canada has released data from more than 160 submissions for drugs, biologics, vaccines and medical devices. The regulator is currently in its third year of a 4-year phase-in schedule to release clinical data proactively from submissions for all new active substances, new clinical indications, generic drugs and higher-risk devices that are approved, withdrawn or rejected. Substantial clinical data submitted by the industry sponsor of the application, including summary-level data (e.g., clinical overviews, clinical summaries and clinical study reports) and metadata (e.g., trial protocols and statistical analysis plans) are made publicly available by Health Canada as a matter of policy.

Health Canada is currently an outlier among medical regulators in releasing these clinical reports proactively. (3) The European Medicines Agency (EMA) suspended proactive publication of clinical reports in 2018, citing cuts in staff caused by Britain's exit from the European Union (Brexit) and its relocation to Amsterdam. The US Food and Drug Administration (FDA) ended its Clinical Data Summary Pilot Program in 2020 after only 1 company volunteered to participate. Notably, the EMA and FDA continue to publish "action packages" proactively, which contain medical and statistical reviews and other regulator-generated documents, but do not include information prepared by drug sponsors, most critical of which are the clinical study reports.

The same sponsor-submitted clinical data for older drug and medical device applications (i.e., approved, withdrawn or rejected before March 2019) are also available upon request through the Health Canada online portal. Requesting these data is straightforward: anyone, regardless of geographic location or nationality, can request and access data at no cost. Through April 2021, Health Canada has published data from 70 submissions for drugs, biologics, vaccines and medical devices in response to information requests, which took 4.5 months to process on...

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