Most US universities still lack clinical trial registration and reporting policies, new study finds
An online survey of US universities published last week found that only 43% have a policy on clinical trial registration, and only 35% have a results reporting policy. Trial registration and results reporting are universal ethical requirements under the Declaration of Helsinki.
Numerous bodies, including the World Health Organization, have repeatedly called for all clinical trials to be registered and their results to be promptly reported.
The study’s authors conclude that:
Key findings by the research team, which was led by Evan Mayo-Wilson of Johns Hopkins University:
Trial registration
Only 46% of existing trial registration policies require registration prior to the recruitment of the first trial participant (an ethical requirement under the Declaration of Helsinki)
Nearly half of existing policies do not require registration of all NIH-funded trials
Many universities have only recently adopted trial registration policies (median = 2013)
Results reporting
Most universities did not seem to clearly allocate responsibility for results reporting
Only 18% of responding institutions with a policy reported that an investigator could be published for not reporting a trial (also an ethical requirement under the Declaration of Helsinki)
Less than one in five universities had an electronic system for managing trial registration or results reporting
Intriguingly, 85% of applicable institutions claimed to monitor compliance with their results reporting requirements; existing studies concur that universities typically perform very weakly at reporting results.
According to the study’s authors, universities could take four immediate steps to improve trial registration and reporting:
“First, organizations could offer education to help investigators understand these requirements.
Second, organizations could implement policies and procedures to support trial registration and reporting. For example, organizations could require that investigators answer questions on IRB applications to identify clinical trials that require registration. Organizations could also require that investigators provide trial registration numbers before allowing trials to commence.
Third, organizations could identify trials that do not meet trial registration and reporting requirements and help individual investigators bring those trials into compliance. Notably, software could provide automatic reminders when trial information needs to be updated or when results will be due, and software could help organizations identify problems that require attention from leaders. Prospective reminders would allow administrators and investigators to update information before they become non-compliant with reporting requirements.
Finally, organizations could ensure there are consequences for investigators who fail to meet trial registration and reporting requirements. For example, organizations could stop enrollment in ongoing trials or stop investigators from obtaining new grants.”
The online survey that formed the basis for the study was conducted between November 2016 and March 2017, so its findings are likely to be slightly out of date, especially as some leading US universities have recently taken significant steps to bring their policies and practices into line with legal and ethical requirements and scientific best practices.
Note: TranspariMED jointly with UAEM-UK is currently preparing to assess the clinical trial registration and reporting policies of major UK universities. We welcome feedback from universities and other stakeholders on how to improve our draft survey instrument.