Concerns about Canada’s dependence on US health research infrastructure: considerations for clinical trials

Since US President Donald Trump’s administration took office just a few short months ago, uncertainty about how Canada is impacted by US federal changes is creating a feeling of crisis. Any changes to the US federal research system will be felt deeply in Canada given how closely our research communities intersect. For example, last year Canada-based researchers accessed more than 40-million dollars in National Institutes of Health (NIH) funding.¹ The recent halt on NIH funding will therefore profoundly impact Canadian research. Any freeze or delays in funding will have a chilling effect, possibly delaying the development of health interventions and cures for patients. Scientists in both Canada and the US have spoken up with concerns.²

Over the first weekend in March 2025, an outage of the US government-funded PubMed database, which is maintained at the NIH, sent many researchers into a panic.³ PubMed serves as critical infrastructure for clinicians, researchers, and empowered patients to access scholarly literature. This temporary outage, which appeared not to be deliberate, highlights the significant role the US plays in maintaining free access to essential research infrastructure. These recent geopolitical changes should prompt leaders in Canada’s health research ecosystem to reflect inward and be mindful about how we conduct and disseminate our research and who controls the platforms we leverage to do so.

There has been recent coverage of researchers in Canada and beyond rushing to “save” data being removed from the US Centers for Disease Control and Prevention’s (CDC) website as a result of Trump’s executive orders targeting diversity initiatives.⁴ Given this purposeful scientific curation by the US government, I don’t think it would be unreasonable to consider what potential data sovereignty risks Canada faces because of its reliance on US infrastructure. Consider clinical trials – these are among the costliest health studies conducted but provide the highest quality of empirical evidence for the effectiveness of an intervention. In line with the Declaration of Helsinki, Canada’s Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) requires that “All clinical trials shall be registered before recruitment of the first trial participant in a publicly accessible registry that is acceptable to the World Health Organization (WHO) or the International Committee of Medical Journal Editors (ICMJE).”⁵ Most Canadian trials are registered on the US NIH-provided infrastructure clinicaltrials.gov.

The reasons to register a trial prospectively are clear. From a scientific perspective, registration helps to mitigate publication bias and selective outcome reporting.⁶ Improving awareness of current or past trials and their results can also help to reduce unnecessary duplication of research effort. From an ethical perspective, clinical trial registries can also be used by clinicians and patients to identify trials and facilitate recruitment. Any lack of funding to the NIH or changes in operations to clinicaltrials.gov could impact Canadian health research. To my knowledge, neither Health Canada nor the Canadian Institutes for Health Research (CIHR) maintains a public record of the results of the clinical trials they fund.

While Health Canada maintains a Clinical Trials Database which provides a listing of trials involving human pharmaceuticals and biological drugs, it is not comprehensive to all Canadian trials. More critically, this database is not the equivalent of a registry as it lacks sufficient details, comprehensive trial information, and subsequent results. Health Canada explicitly encourages sponsors to register their trials in a publicly available registry like clinicaltrials.gov. Canadians may ask themselves, are we comfortable with the only public-facing, systematic, and comprehensive account of our ongoing and past trials being hosted in the US? Does the current administration pose threats to the sovereignty of this data? Is summary data on trials that use a gender-based analysis approach, or that relate to diversity, likely to be impacted by the executive order?

In the long term, Canada might consider developing its own infrastructure to deal with clinical trials registration and results reporting. This approach has been carried out by other jurisdictions. However, the most obvious and expedient solution could be to partner elsewhere, such as with the ISRCTN registry, which is a not-for-profit entity used in the UK.⁷ Unlike clinicaltrials.gov, there would be a fee charged for using this registry. User fees maintain the free-to-access registry, support researchers using the registry, and provide patient-friendly content. While this route is not without cost it might be a less risky pathway well worth the investment.

Am I being paranoid to consider that clinicaltrials.gov might go down or be modified? Perhaps. But it is possibly less unreasonable to think that the US government may not want Canada to freely piggyback off its infrastructure forevermore. This US government is disrupting science, the impacts of which are felt well beyond their borders. Scientists are mobilizing through protests to stand up for science and to speak out about how recent actions threaten to disrupt the scientific process. Given our deep intertwining with the NIH, it will pay for Canadians to be active in this effort, too.  

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