Clinical Trial Registration and Results Disclosure Policy
2025 Monitoring Executive Summary
CIHR's Monitoring of Clinical Trials Registration and Disclosure – 2025
MR4-217/2026E-PDF
ISBN 978-0-662-30095-3
What is the Canadian Institutes of Health Research (CIHR) commitment?
In line with best practices in open science and to contribute to global research excellence, CIHR formally signed onto the WHO Joint Statement on public disclosure of results from clinical trials in 2020. In doing so, CIHR affirmed its commitment to reduce research waste by implementing a policy guide that requires transparency and public disclosure of CIHR-funded clinical trial results. CIHR monitors policy compliance annually for all ongoing clinical trials funded on or after January 1, 2022, and will publicly report aggregate data showing the degree of compliance with the policy requirements. Ultimately, non-compliance can result in the withholding of new CIHR funding until compliance has been achieved.
Why monitor clinical trials?
There are strong ethical and financial reasons to prevent research waste in clinical research. The real-world impact of clinical trials is limited by wasteful research practices, such as when a lack of transparency in the conduct of trials (i.e., not registering a trial and the non-disclosure of results) leads to duplication of research or withholds from society the knowledge gained from research investments.
How was the policy monitored for the 2025 monitoring cycle, and what did we learn?
The 2025 monitoring cycle included clinical trial grants with a funding start date between January 1, 2022 - December 31, 2025. A compliance report (a questionnaire evaluating each requirement of the policy) was sent to all Nominated Principal Investigators (NPIs) of CIHR-funded clinical trials to evaluate policy compliance. Results show that:
Long description
- 599 CIHR-funded clinical trials were monitored (2022-2025)
- 99.2% of Nominated Principal Investigators responded to the compliance report by data cut-off
- 80.0% of respondents had reached the step of registering their clinical trial in a publicly available registry
- 94.8% of respondents hadn't yet published results
- CIHR monitored 599 clinical trials that had funding start dates between 2022 and 2025.
- Compliance reports were received for 594 of the 599 clinical trials, a 99.2% response rate, over the course of the monitoring cycle (including follow-ups).
- 470 (79.1%) NPIs confirmed that they had registered their clinical trial in a publicly available, free to access, searchable clinical trial registry complying with WHO's international agreed standards before the first visit of the first participant. A further 5 respondents answered "yes" to the question of trial registration, but did not use a WHO-approved registry, or did not specify the registry used. The remaining respondents indicated they were in the early stages of trial start-up and working towards registration.
- Fifty-six (56) grants (9.4%) reported having reached their trial's date of primary study completion, defined as the last data collection timepoint for the last subject for the primary outcome measure.
- Thirty-one (31) grants (5.2%) reported a total of 59 publications. These included publications of trial results, results posted to the registry, conference proceedings and protocol publications. All other respondents had not yet reached the stage of reporting results. Among grants reporting publications >90% had also reported including the registration number/Trial ID in the publication.
Although 20.0% (119) of respondents had not reached the step of registration by the reporting deadline, teams reported working towards registration and having achieved milestones such as having applied for research ethics board and regulatory approval or awaiting approval from the registry, all rate-limiting steps associated with study start-up. Furthermore, registration rates increased with each passing year. The average registration rate for trials within the first year of receiving funding was 56.1%, in the second year of monitoring that figure rose to 80.2%. Among trials first funded in 2022, 91.9% are registered, and those that are not have faced logistical hurdles and are not yet recruiting, indicating compliance with this policy requirement.
For those trials which have started publishing results, not all reported publications were immediate open access, suggesting that further engagement is required to support researchers in becoming fully compliant.
In this fourth year of monitoring, the process developed for executing a coordinated, efficient, and thorough data collection effort continues to be successful. Despite the important increase in the number of trials monitored, a strong response rate was sustained.
We would like to thank the researchers and their institutions for their timely responses.
New this year
NPIs can now notify CIHR if their trials meet the criteria for discontinuation from monitoring (Question 4 of the FAQ), for reasons of trial cessation or study completion. This is a natural step for trials as they end. To date, four years into monitoring, only two trials have met the requirements.
What's next?
As part of its ongoing efforts to promote a research culture of open science, CIHR continues to engage with the 0.8% of NPIs who did not submit the compliance report to identify barriers in meeting this basic requirement of compliance. Enforcement activities are planned after a full analysis of 2025 monitoring data, as are updates to policy guidelines, to ensure CIHR's continued alignment with international best practices. General information about the policy continues to be communicated with partners, the research community and the public. CIHR remains committed to annually monitoring compliance and reporting on the results.
For additional information, please contact clinicaltrials-essaiscliniques@cihr-irsc.gc.ca.
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