Canada's CIHR: Publish your clinical trial results or we will cut off funding

Canada's public medical research funder CIHR has announced that it will refuse to provide new funding to researchers that fail to make their clinical trial results public. In parallel, Health Canada is mulling ways to improve trial reporting nationwide.

The announcement comes in the wake of a recent study that found that over a third of clinical trials involving Canadian patients never made their results public in any form, and brings CIHR into line with the commitments it made in when it signed the WHO Joint Statement in 2020.

CIHR's new policy on trial reporting

CIHR's press office provided TranspariMED with the following statement:

"As a signatory to the World Health Organization’s Joint Statement on Public Disclosure of Results from Clinical Trials (“WHO Joint Statement”), CIHR has implemented a policy requiring the registration and disclosure of results from clinical trials. Details are available in the Policy Guide."

"CIHR previously aligned with the WHO Joint Statement requirements for CIHR-funded trials to be registered through existing Tri-Agency policies, including the Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans (TCPS2). The requirements outlined in the Policy Guide, including the disclosure of trial results within a mandated timeframe, apply to all clinical trial grants funded on or after January 1, 2022 and are not retroactive."

"CIHR is developing monitoring processes, and has committed to annually publish aggregated, anonymous data indicating the degree of compliance with the policy. This will begin in 2023. Nominated Principal Investigators found to be non-compliant as a result of purposely contravening the requirements of the WHO Joint Statement will not be eligible for any new CIHR funding."

Silence about past research waste

CIHR did not respond to a question by TranspariMED about what the funding body intends to do about its many past trials that have apparently remained unreported.

Till Bruckner, founder of TranspariMED, said:

"TranspariMED strongly welcomes CIHR's plans to ensure that all publicly funded clinical trials in Canada will henceforth make their results public, and applauds CIHR's intention to publish annual compliance monitoring reports."

"At the same time, CIHR should not walk away from older unreported trials involving Canadian patients that were funded with Canadian taxpayers' money. Together with partners in Canada, TranspariMED will continue to urge CIHR to audit all trials it has funded in the past to identify those that have remained unreported, and to follow up with the institutions and investigators that ran those trials until their results have been made public."

"Following up on past unreported trials is not only a fiduciary and ethical imperative, but it also a highly cost-effective way to reduce research waste and increase the global store of medical knowledge."

Health Canada plans overhaul

Health Canada provided TranspariMED with the following statement:

"Health Canada is committed to enhancing transparency of authorized clinical trials conducted in Canada. In support of this commitment, the Department completed public consultation on the Clinical Trials Regulatory Modernization Initiative, which outlines key policy proposals for the modernization of Canada's clinical trials regulatory framework. This includes proposals for increasing transparency of Canadian clinical trial information to ensure that people have access to the information they need to make informed decisions about their health."

"The feedback received during the consultation will be used to better inform decision-making with respect to proposed policy, regulatory, and program considerations for each product line (drugs, medical devices and natural health products). Health Canada published a "What we heard" report summarizing the comments received during the consultation process."

"The transparency-related proposals include elements relating to registration of Canadian trials, public disclosure of results (results reporting), and making Canadian clinical trial information more accessible and easier to find."

"Health Canada will be publishing a draft guidance for consultation in 2023, along with a demonstration of a new portal that will link users to authorized trial records, including summary results, in international registries. The implementation of a policy-first approach will give researchers time to develop or augment their existing practices associated with registration and results reporting, before future regulations may be put in place."

Canadians call for new transparency rules

According to the consultation summary published by Health Canada:

"Most respondents saw value in a new transparency policy and/or regulations for registering trials and reporting results."

"Support was strongest from the academic community (73%) compared with industry (54%). There were general statements of support for an updated policy or new regulation and the potential benefits this would have for people living in Canada. One academic says, 'Far too often, the outcomes are not known, shared or easy to find.'"

Surprisingly, the summary notes that "Most respondents from industry and academic research institutes (73%) report their results in international registries." In contrast, a recent study found that only 39% of Canadian trials adhere to this WHO best practice, which can help to avoid research waste and accelerate medical progress. Looking forward, respondents opposed the creation a separate Canadian trial registry.

Consultation respondents suggested aligning Canadian clinical trial registration and reporting requirements with international regulations.

Till Bruckner, founder of TranspariMED, said:

"Hopefully Health Canada will listen to the Canadian medical research community and align national legislation with WHO best practices and regulatory standards in the United States, the European Union and the UK."

"Specifically, this means requiring all interventional clinical trials (as defined by the WHO) to be prospectively registered and their results to be made public on a trial registry within 12 months of trial completion, plus compliance monitoring coupled with sanctions."

"The UK's national clinical trial transparency strategy may provide a useful point of reference."

Cochrane, Transparency International and TranspariMED have previously highlighted that global regulatory experience clearly shows that trial transparency rules can only be effective if they are backed up by effective sanctions mechanisms.

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