Getting Transparent About Transparency: Canadian Registration and Reporting of Clinical Trials

Clinical trials are vital to the advancement of modern medicine, leading to the generation of new treatments and diagnostic methods. Just as important as these medical advances is demonstrating unsuccessful outcomes. Knowledge of unsuccessful trials points researchers in the right direction and reduces research waste. Yet, for this system to succeed, researchers must comply with the registration and reporting of clinical trial data. The current clinical trial system, in Canada and around the world, is underperforming, with a lack of adherence to best practices when it comes to registration and reporting.

A recent publication by Alayche et al., indicated that Canada is lagging when it comes to clinical trial compliance. Alayche analyzed 6,790 clinical trials conducted in Canada between 2009 and 2019 and found that less than two-thirds were prospectively registered, less than two-thirds published their findings and less than one-quarter completed all three best practices (registered, reported, published).

In Canada, for many years adherence to best practices has been voluntary, with little to no consequences for failing to comply. According to the Health Canada Guidance Document For Clinical Trial Sponsors, sponsors should register their clinical trials.  In the United States, The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires registration of trials and reporting of results.  Even with this requirement, there are still reporting issues.  In 2020 a federal judge ruled that hundreds of clinical trials had missing data that must be reported to ClinicalTrials.gov^[1]. As of December 2022, the FDA has sent four notices of non-compliance for failure to report results, giving these non-complying companies 30 days to submit the required information. All four companies have since complied with the requirements.

Although Health Canada may not be putting pressure on researchers, the Canadian Institutes of Health Research (CIHR) is requiring minimum clinical trial best practices. On October 28, 2020, CIHR signed the joint statement on public disclosure of results from clinical trials. The joint statement encompasses the Declaration of Helsinki which states:

Article 35. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.

Article 36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

In signing the declaration, CIHR has affirmed “that the prospective registration and timely public disclosure of results from all clinical trials is of critical scientific and ethical importance. Furthermore, timely results disclosure reduces waste in research, increases value and efficiency in use of funds and reduces reporting bias, which should lead to better decision-making in health.”

Keeping true to their word, in 2021 CIHR implemented new policy requirements for clinical trial researchers:

• Clinical trials must be registered 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

This is a positive development for reporting on clinical trials.  In our next article, we will review these requirements in more detail.