Advocacy Group Worries European COVID-19 Trials Won’t Publish Results
A majority of European clinical trials of COVID-19 drugs are being run by universities and companies who either lack experience or have a poor track record in uploading their results to the EU’s trial database, which could lead to wasted research, according to a new report.
The report, issued by the nonprofit research advocacy group TranspariMED, analyzed 118 clinical trials of potential COVID-19 treatments across Europe and found that a majority of them (79) are being conducted by researchers who have never uploaded clinical trial results onto EudraCT, the EU’s clinical trials database.
Of those, 39 are being run by sponsors who have violated the EU’s trial transparency regulations in the past, while 40 trials are being run by sponsors that have never completed drug trials before and have never engaged in the uploading process, TranspariMED determined.
Only eight of the remaining 39 trials are being conducted by sponsors that have been fully compliant with the EU’s trial transparency rules.
“The large number of COVID-19 trials run by noncompliant and inexperienced trial sponsors poses a threat to the accuracy and utility of data on EudraCT, creating a high risk of research waste,” the group said. “This undermines the global search for safe and effective COVID-19 drugs.”
The report called for policy action to help address the issue. For example, it called on EU regulators to keep a close eye on COVID-19 trials in their countries and reach out to companies and universities to inform them of their data uploading obligations. They can go further by actively monitoring compliance and providing sponsors with guidance and training materials, the group said.
Additionally, regulators should encourage sponsors to upload their results as soon as possible after their trials conclude, rather than within 12 months as currently required by EU regulations since 2014, and sanction those that neglect to make their trial results public.
“Billions in public money are currently being spent on medical research across Europe, but those investments will only benefit patients if research findings are made public,” said TranspariMED founder Till Bruckner. "National regulators urgently have to step up and start closely monitoring the COVID-19 trials they are responsible for, and impose sanctions on those trial sponsors that violate the rules.”
Read the full report here: www.fdanews.com/06-18-20-RiskofResearchWaste.pdf. — James Miessler