An analysis of more than 6,700 clinical trials conducted and completed in Canada between 2009 and 2019 revealed widespread non-compliance in registration and reporting best practices, a new study led by researchers at the University of Ottawa Heart Institute (UOHI) has found. The research is published in FACETS, a multidisciplinary open access science journal.
“Adherence to study registration and reporting best practices are vital to foster evidence-based medicine,” writes Mohsen Alayche, a medical student at the University of Ottawa and the paper’s corresponding author. “Poor adherence to these standards in clinical trials conducted in Canada would be detrimental to patients, researchers, and the public alike.”
All registered clinical trials on ClinicalTrials.gov conducted in Canada as of 2009 and completed by 2019 were identified. A cross-sectional analysis of those trials assessed prospective registration, subsequent result reporting in the registry, and subsequent publication of study findings.
- Only 59% of all trials were registered prospectively.
- Only 39% of all trials reported results in the registry.
- Of the trials registered between 2009 and 2014, only 55% were subsequently published in an academic journal.
- Of the 3,763 trials conducted exclusively in Canada, only 3% met all three criteria of prospective registration, reporting in the registry, and publishing findings.
“Canada is falling short of its international commitments to register and report all clinical trial results,” said Kelly Cobey, PhD, a scientist at the UOHI, and a co-principal investigator of the analysis. “This has implications in terms of fiscal waste, but it also indicates we are failing to honour our commitment to the patient participants who contributed to these trials. If trial results never see the light of day, it means that our available evidence to inform healthcare is biased.”
“Knowledge of this widespread non-compliance should motivate stakeholders in the Canadian clinical trials ecosystem to address and continue to monitor this problem,” the paper concludes.
For more information
To conduct an interview with Kelly Cobey of the University of Ottawa Heart Institute, please contact the liaison below.
Leigh B. Morris
University of Ottawa Heart Institute