Adherence to study registration and reporting best practices are vital to foster evidence-based medicine. Poor adherence to these standards in clinical trials conducted in Canada would be detrimental to patients, researchers, and the public alike.
The registration of clinical trials and the publication of trial results are fundamental to the integrity of clinical trials and clinical practice. They ensure that there is efficiency in future researchers knowing whether there is a need for a clinical agent to be tested. It also means clinicians know whether it is safe to use an agent in their care. When there is no registration of a trial or publication of trial results, it raises the question of whether the findings were not in accord with the wishes of the trial sponsor. Canada is definitely not the only country with poor levels of registrations and publication. Nevertheless, it is still a serious concern.
A total of 6,720 trials met the inclusion criteria. From 2009-2019, 59% (n=3,967) of them were registered prospectively and 39% (n=2,642) reported their results in the registry. Of the trials registered between 2009-2014, 55% (n=1,482) were subsequently published in an academic journal. Of the 3,763 trials conducted exclusively in Canada, 3% (n=123) met all 3 criteria of: prospective registration, reporting in the registry, and publishing findings. In contrast, of the remaining 2,957 trials with both Canadian and international sites, 41% (n=1,238) had an overall compliance to these three criteria. Overall, the odds of having adherence to all three practices concurrently in Canadian trials decreases by 95% when compared to international trials (OR = 0.05; 95CI: 0.04 – 0.06).