New study flags rampant research waste in Canadian clinical trials
Over a third of clinical trials involving Canadian patients never made their results public in any form, a new study following up on almost 7,000 trials completed between 2009 and 2019 finds.
In addition, over a third of trials were only retrospectively registered.
These widespread failures to pre-register trials or make their results public are a clear breach of medical research ethics, harm patients, waste research funds, and undermine public health.
Lead author Mohsen Alayche told STAT News that:
“Ultimately, this is detrimental to taxpayers and to patients, but especially patients. Without certain disclosure standards, patients will try certain interventions over and over again, because they were never reported or published."
"It’s horrible. Canada is just abysmal.”
Trial registration in Canada improved significantly between 2009 and 2019, but there was little positive momentum on outcome reporting metrics.
Academic trials perform appallingly
The study found that trials taking place exclusively within Canada (as opposed to multi-country trials), and trials run by academia, performed especially badly.
Of trials conducted exclusively in Canada, only 3% met the triple WHO best practice benchmarks of prospective registration, results publication on trial registries, and publication in an academic journal. In contrast, 41% of international trials including Canadian patients met all three benchmarks.
Only 5% of academic trials met all three WHO benchmarks, compared to 36% of industry-led trials.
Patients "likely to be disappointed"
The authors conclude that:
“Patients, who are critical to the success of clinical trials, are likely to be disappointed with these results; their contributions are not being honored.”
“For healthcare funders, these results indicate a bad return on investment. If grantees use scarce resources, often taxpayer dollars, and do not prospectively register their trials and/or make their results available in registries or publish their results, everyone loses.”
New CIHR transparency rules
The study notes that the Canadian Institutes of Health Research (CIHR) committed to requiring that their grantees follow WHO best practices in trial registration and reporting in late 2020, and put relevant policies into place at the start of 2022.
Weak laws and no enforcement
STAT News reported that:
"Canadian law... does not have provisions for requiring clinical trial sponsors to register their studies, report results or publish findings, according to [Canadian legal expert Matthew] Herder."
"A law was passed in 2014 that addresses the issue, but lacks enforcement powers and only requires clinical trial data to be disclosed — on a portal — for drugs that are currently marketed."
Medical evidence lost forever?
Till Bruckner, founder of TranspariMED, said:
“This study highlights the urgent need for Canadian policy makers to introduce legislation mandating the registration and reporting of all clinical trials, as the UK is currently doing.”
“Meanwhile, CIHR should not limit itself to preventing research waste going forward. CIHR should audit its entire past funding portfolio and chase up all unreported trials until their results have been made public.”
“Otherwise, medical evidence that probably cost hundreds of millions of taxpayer dollars to generate will be lost forever. New Zealand’s public research funder is already doing this – why should Canadian patients settle for less?”
The study’s results have been published as a preprint. The authors have made their dataset of trials publicly available for analysis by other researchers.