Only 3% of all clinical trials conducted in Canada meet international requirements when it comes to registration and reporting best practices, according to a study of more than 6,700 trials.
The study, published in the Facets Journal, found that between 2009 and 2019 only 59% of all trials were registered prospectively and 39% of trials reported results on the registry. Only 55% were published in an academic journal from 2009 to 2014.
The report titled ‘Evaluating prospective study registration and result reporting of trials conducted in Canada from 2009 to 2019’ was conducted by the University of Ottawa.
Corresponding author Mohsen Alayche said: “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 Canadian report reads: “Some readers will view these results as another example of egregious waste in biomedicine with little improvement since the 2014 landmark Lancet series on research waste.
“Patients, who are critical to the success of clinical trials, are likely to be disappointed with these results; their contributions are not being honoured. For clinical practice guideline developers, these results indicate that evidence is missing regarding the totality of knowledge about an intervention. For healthcare funders, these results indicate a bad return on investment.”
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The report goes on to detail how academic institutions may risk their institutional reputation when their faculty members fail to meet minimum reporting requirements and that it may reflect that clinical trial principal investigators are leaving these responsibilities to other team members. Also, it noted that the trial sponsors may not have a strong enough adherence monitoring system in place.
Other regulators are also tackling the lack of transparency and reporting in clinical trials. In October 2023, the European Medicines Agency (EMA) revised its transparency rules on publishing information about clinical trials submitted through the Clinical Trials Information System (CTIS) with the aim of expediting access to trial information for stakeholders.
Transparency has been a key area of development for many countries when it comes to clinical trials. Recently, Clinical Trials Arena spoke with Nicholas DeVito of Oxford University, who worked to develop trial trackers for both the EU and the US that follow which trials reported required data.