March 2022: Canada update

The article “Pharma is still burying clinical trial results in Canada, new study warns” has been published on March 23, 2022, on TranspariMED.

According to the Canadian research team, Canada lacks regulatory requirements as some pharma companies continue to prevent clinical trial results from being made public. Trials that showed harm or safety concerns were not published.

Health Canada and research institutions in Canada have an obligation to ensure that site investigators are able to report trial findings based on all data from multisite trials, when sponsors and trial leaders do not proceed with timely reporting.

The World Health Organization recommends that “Legislation or supporting regulations [should include] sanctions if a clinical trial is not registered and/or results are not reported.” The WHO has long demanded that the results of all interventional clinical trials be made public on a registry within 12 months of trial completion.

The Canadian study identified seven key themes related to industry influence on clinical trial reporting:

  1. Sponsor influence on decision-making about whether to publish
  2. Weaker incentives to publish trials with negative findings or evidence of harm
  3. Stopping trials early and not reporting stopped trials
  4. Ownership and control of data
  5. Clinical trial agreements and confidentiality restrictions
  6. Nonpublication of internal company trials
  7. Dependency on funding from industry-sponsored trial