Canadian Grant Agency Raises Clinical Trial Reporting Requirements

Our earlier article [available here] reviewed the Canadian landscape for clinical trial reporting.  This article will review in detail the 2021 CIHR policy requirements for clinical trial reporting.  The policy requires clinical trial results to be provided in a free, public, searchable database that complies with WIPO standards, prior to commencing the human testing. 

More specifically, the following new requirements apply to all clinical trial grants funded on or after January 1, 2022:

• Public disclosure of results must be done within a mandated time frame:
  • publications describing clinical trial results must be open access from the date of publication;
  • summary results must be publicly available within 12 months from the last visit of the last participant (for collection of data on the primary outcome); and
• All study publications must include the registration number/Trial ID (to be specified in the article summary/abstract).

Nominated Principal Investigators receiving CIHR grant funds for clinical trial research after January 1, 2022, must comply with the above requirements in order to remain eligible for any new CIHR funding.

Notably, CIHR is backing up these requirements with consequences for researchers who fail to adhere to the rules. CIHR will monitor compliance with the policy annually, and those found contravening the policy will have funding withheld until requirements have been met.

As the regulations only took effect last year, it remains to be seen how strictly CIHR will hold researchers to these requirements. Hopefully, the looming threat of lost grant money will be enough to encourage prompt registration and reporting.

It is also worth noting that The International Committee of Medical Journal Editors (ICMJE) requires clinical trials to be registered in order to publish in an ICMJE journal. This policy was put into effect in 2005, and according to ICMJE lead to a significant uptake in trial registration. While registration numbers may have increased, there is still room for improvement. According to a 2018 study published in Trials, journals continue to publish unregistered trials and trials registered retrospectively.

Compliance with clinical trial best practices not only advances medicine and science, but increases transparency, enabling evidence-based decisions and instilling trust amongst both patients and researchers. Transparency of clinical trials has become an increasingly important topic yet, only about half of clinical trials are published, and even less for those trials with negative results.^[1]

Even Health Canada has also called for improved transparency of clinical trials. Health Canada held a consultation on the Clinical Trials Regulatory Modernization Initiative in 2021. The results of the consultation indicate support for a new transparency policy and/or regulations for registering trials and reporting results.^[2] Transparency is one of the 5 pillars under Health Canada’s Regulatory Innovation Agenda. Accordingly, Health Canada intends to align with international best practices on matters related to oversight and public access to information.

Part of this international alignment includes the Public Release of Clinical Information initiative. This initiative allows public access (for non-commercial purposes) to the clinical data submitted as part of the regulatory review process. While this does not address the trial registration issues, it does help bridge the gap in clinical trial reporting. The public release of approval data helps ensure that data is not “cherry-picked” for publication, thereby increasing transparency in reporting. However, since this release relates only to clinical data submitted for approval, those trials which are unsuccessful and thus do not seek approval would be missed by this initiative.  

Unfortunately, clinical trials are not immune from publication bias. Everyone wants to be able to report a successful outcome, rather than demonstrating an intervention does not work or has adverse effects. Despite the jokes about the Journal of Negative Results amongst researchers, this data is just as important as positive results. Moreover, the ability to tailor a journal publication to tell a story is not the same as full reporting of clinical trial data. There needs to be a research culture shift, focusing more on the value of full, transparent clinical reporting and less on the end goal of publication. Canada has taken the first step in recognizing the need for transparency, but now these words need to be put into action.