Unveiling the Gaps: Year One of CIHR’s Clinical Trial Registration Rules
Data transparency is becoming a priority for life sciences research. It is a good time for Canadian researchers to refresh themselves on best practices when it comes to data sharing. As a condition of funding, CIHR reminds applicants that “CIHR is a signatory to the World Health Organization’s Joint Statement on Public Disclosure of Results from Clinical Trials (“WHO Joint Statement”) requiring all clinical trials to be registered and the results disclosed publicly in a timely manner.” See our previous article for an overview of these requirements.
CIHR signed the Joint Statement in 2020 and implemented the new policy effective January 1, 2022. Although this initiative is still in its infancy, CIHR released an Executive Summary of the Monitoring of Clinical Trials Registration and Disclosure for 2022.
CIHR appears to be taking a gentle approach to the new rule roll out. CIHR acknowledged that clinical trials are a lengthy process, and that a research culture shift is a gradual process. Accordingly, the survey sent to 2022 grant recipients was focused on trial registration rather than trial reporting. Of the 154 funded trials, only 82 responses were received. Of those 82 responses only 47 (57.3%) of grant recipients indicated 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.
The summary did note that many studies indicated that they were still in the early stages of trial start-up and still working towards registration. Unfortunately, the summary does not further break down the data. It is unknown how many recipients were beyond the trial start up stage but had not registered the trial. This data should be made available, since it is critical to the public understanding the actual compliance rate on clinical trial registration.
The data is further complicated by the fact that some trials had received funding prior to 2022, and thus began the trial prior to the introduction of the registration rules. For instance, 3 studies – which had registered their trials – had published trial findings as the trials began prior to the 2022 funding. Yet, it is unclear how many trials that began prior to 2022 have neither registered nor reported trial results. This data should also be made available.
It remains to be seen how CIHR plans to deal with trials that began prior to the rule change but received funding in 2022 and beyond. Perhaps it would be reasonable to have a requirement that the trial be registered prior to the release of new funding.
CIHR has indicated that they continue to follow up with grant recipients that did not respond to the survey in order to identify barriers and work collaboratively towards compliance. The summary did indicate that CIHR will continue to report annually, and importantly that deliberate non-compliance, which may result in funding ineligibility, will be implemented in the next CIHR funding cycle.
This enforcement may be necessary to ensure full compliance with best research practices. Implementation and enforcement of CIHR’s registration and reporting requirements may be the catalyst for a long overdue shift in research culture.