No regulation, no consistent reporting of results. That is the conclusion of a recently published study based on interviews with 34 Canadian clinical trialists and expert stakeholders.
Recent research has shown that over a third of almost 7,000 trials clinical trials involving Canadian patients never made their results public in any form - a clear breach of medical research ethics that harms patients, wastes research funds, and undermines public health.
According to the authors of the interview study:
“Our study suggested that research institutions may be unlikely to address the issue of unreported trials in the absence of external pressure to take action. Moving toward full reporting of clinical trial results will probably depend on effective regulatory requirements to report trial results.”
Lack of institutional oversight
The researchers discovered that that Canadian research institutions and ethics boards currently lack policies and practices to ensure that trial findings are reported in registries or journals.
“When asked whether his research group had any policy related to clinical trial reporting, an oncologist said he was not aware of one, and added: ‘Based on my past experience, there is nobody making sure that my work is published’.”
“One administrator was involved with efforts to promote trial reporting through what he referred to as a ‘soft approach’, including an initiative to monitor whether registered trials were reported and remind investigators about trials with unreported results, and a pilot project facilitating the use of protocol development software that would make it easier to report findings within ClinicalTrials.gov. However, these efforts were preliminary and hindered by a lack of guiding policy and a lack of resources.”
One administrator noted that “with thirty other competing priorities – without either media attention or a federal policy telling you have to do something – [trial reporting] slips.”
Ethics boards cannot solve the problem
Research Ethics Board members interviewed for the study highlighted that Canadian REBs are overburdened and lack the necessary resources to audit trials they approved in the past to check whether their results were made public. However, one REB member told the researchers that:
“If the university as a whole feels that it is important, then we can advocate for it, and make the university pay for this decision and then do it.”
Several investigators interviewed were supportive of regulators playing a role in ensuring clinical trials are reported, if necessary backed up by the threat of fines.
Regulation in U.S. and Europe works
Past efforts to fix the costly scandal of clinical trial non-reporting through ‘changing research culture’ have miserably failed. In contrast, international experience shows that regulation works.
As a result of regulation (and some public pressure), all major U.S. medical research institutions have put centralised compliance systems in place, as have leading institutions in those European countries where regulators have been especially proactive.
In the UK, a combination of regulation and public and political pressure sparked the development of the world’s first watertight national system to ensure that all trial results are made public. (While research funder policies such as the new CIHR policy are incredibly useful, these only cover some trials.)
The Canadian interview study, Factors relating to nonpublication and publication bias in clinical trials in Canada: A qualitative interview study, is available online.