Report cards and incentives promote transparency in drug trials, analysis says

Feedback tools, such as “report cards,” designed to increase transparency in drug trials are most effective when investigators are incentivized and given institutional support, according to new analysis.

The findings were presented in a study by researchers at the Quest Center for Responsible Research in Berlin, Germany, who argue that transparency is a vital part of building trust in clinical trials.

“The inability to reproduce scientific findings and the non- or incomplete reporting of research results have raised concerns about research waste and highlighted the need to promote responsible research practices to increase research value,” the study said.

“Transparency is core to responsible research: transparency practices allow the quality of research to be appraised, mitigate biases, discourage poor methodological practices, and facilitate comprehensive evidence synthesis.

Most efforts to make trials more transparent are “top down” – policy and monitoring driven – according to the authors, who suggest that, in addition, tools that encourage transparency at investigator level should be considered.

“Improvement ultimately requires researchers to take specific actions, such as report results and methods in a timely manner and in sufficient detail. Thus, effective research reform also requires bottom-up approaches to empower researchers through feedback and guidance on transparency at the level of individual studies.”

Transparency tools

To evaluate the idea, the Quest team developed tools that provide feedback and guidance to investigators.

“We designed individualized ‘report cards’ that summarize the performance of a given clinical trial across several transparency practices and provide tailored guidance for improvement. We also created an infosheet with an overview of recommended transparency practices and relevant guidelines and regulations,” the authors wrote.

To assess the approach, they conducted a single-arm exploratory study at Charité – Universitätsmedizin Berlin, providing investigators with report cards and an “infosheet.” They quizzed them on the usefulness of the tools, then examined the overall impact on defined transparency measures.

And, in terms of usefulness, the findings were positive.

“Overall, researchers found the tools helpful to inform them of the transparency of their trial and to raise awareness of relevant guidelines, laws, and resources,” the authors wrote.

However, the tools had less of an impact on transparency, according to the authors, who added, “Improvement on transparency practices was minimal and largely limited to linking publications in registries.”

They concluded, “While these tools were positively received by investigators, the limited improvement in transparency practices suggests that awareness alone is not sufficient to drive improvement.

“Future research and implementation efforts may adapt the tools to further practices or research areas and explore integrated approaches that combine the report cards with incentives and institutional support to effectively strengthen transparency in research.”

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