Using ‘report cards’ to improve clinical trial reporting
Researchers in Berlin have developed and tested a new approach to improving clinical trial transparency.
It involves sending individual investigators ‘report cards’ that detail which aspects of trial registration and reporting they did well on in the past, where they fell short of global best practices, and practical advice on how to improve their performance in future.
What are trial report cards?
The report cards give individual researchers feedback on their clinical trial transparency performance. They are automatically generated and sent to the investigator who ran the trial.
They provide information on the degree to which a specific clinical trial has matched up to best practices. This includes prospective registration, availability of summary results, and open access publication. They include an information sheet that summarizes relevant laws and guidelines, and flags useful resources.
How were they tested?
A team at the BIH QUEST Center in Berlin sent 92 investigators individualised report cards detailing the transparency performance of 155 completed clinical trials. The team later surveyed investigators, and checked whether they had taken steps to improve the relevant trials’ reporting.
Did the report cards work?
To measure impact, the team assessed each trial for three transparency practices that could still be changed after trial completion:
Reporting of summary results in a registry
Hyperlinking publications within a registry
Open access status of publication
After a year of follow-up, the intervention only seemed to have driven additional linking of publications in registries. However, a majority of respondents found the cards helpful to build awareness of transparency requirements.
It is unknown whether the researchers who received the cards will implement stronger transparency practices during future clinical trials.
What comes next?
According to the study authors:
“As our aim was to test the feasibility of delivering such an intervention, the lessons learned may inform a larger randomized controlled trial… The report cards were designed for scalability and extensibility."
“The report cards may also be adapted for use in other types of studies and disciplines… The report cards may be particularly well suited to help funders monitor and support compliance with grant requirements, which typically span the entire project lifecycle.”
“Future work may also consider evaluating prospective use of the tools: report cards that prompt investigators before a specific practice is due; an infosheet disseminated at study start (e.g., ethics approval) that sets out expectations for researchers before the work is conducted.”
Further reading
The study “Improving research transparency with individualized report cards: A feasibility study in clinical trials at a large university medical center” has been published as a preprint. The study code and data are publicly available.