Over half of COVID trials in Europe may never make their results public
The results of over half of COVID drug trials currently being run in Europe are at high risk of becoming research waste, a TranspariMED report released today shows.
Out of 118 clinical trials of potential drug treatments, 79 trials are being run by companies and institutions that have no experience of uploading results onto the European clinical trial registry.
This means that they may never make the results of their COVID trials public, especially if the trials showed no benefits from the drugs being tested or got terminated early.
Trials that get terminated early, before they have enrolled the original target number of patients, are of particular concern.
Because of their small size, such trials are often of little interest to prominent medical journals, giving researchers little incentive to publish their outcomes. However, taken together, the results of many small trials can provide valuable and potentially life-saving information on the effectiveness and safety of potential COVID treatments.
As the first wave of infections was less severe than expected in most European countries, creating a ‘shortage’ of patients, many COVID trials seem likely to be terminated early.
Under European Union rules, the results of these trials have to be made public on the European trial registry EudraCT. In theory, this should ensure that the results of all COVID trials become available to the scientific community, even if they are not published in medical journals.
However, because national medicines regulators in EU member states do not enforce these rules, compliance is often weak.
A closer look at the COVID trials being run in Spain and France illustrates widespread problems.
National regulators in these two countries are responsible for overseeing more than half of the 118 COVID drug trials in Europe: 48 trials in Spain, and 22 trials in France.
Of the 48 COVID trials in Spain, 46 trials are run by sponsors who have never uploaded a single trial result onto the registry.
Not a single Spanish COVID trial sponsor is fully compliant with European transparency rules, indicating that Spanish national regulator AEMPS is doing little or nothing to enforce the rules.
For example, FFIS, a public research body, is currently in violation of transparency rules, and has failed to keep its registry data up to date. FFIS is currently running two COVID trials.
The picture is similar in France, where national regulator ANSM is responsible for overseeing 22 COVID trials.
Only one of the sponsors of those trials - CHU d’Angers – appears fully compliant with transparency rules. Six trials are sponsored by Assistance Publique – Hôpitaux de Paris, which has failed to upload the results of over 90% of its past trials. None of the other sponsors in France has ever uploaded a trial result.
Reacting to the report, Thomas Senderovitz, director general of the Danish Medicines Agency and chair of the Heads of [European] Medicines Agencies group told STAT News that:
"[I]t’s fair to raise a flag and remind everyone they should make clinical trial data public according to legislation. We take it very seriously that sponsors are very meticulous in filing their results."
Till Bruckner, founder of TranspariMED, said:
“Hidden clinical trial results threaten to undermine the search for safe and effective treatments for COVID-19. 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."
"Many national regulators have clearly been neglecting their responsibility to ensure that companies and research institutions make all results from clinical trials public."
"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.”
Jaume Vidal, Senior Policy Advisor at European Projects at Health Action International, said:
"Lack of transparency in clinical trials reporting continues to be an obstacle to scientific progress. There is no need for additional obstacles when facing a pandemic of global proportions. Authorities have the duty and moral obligation to enforce existing regulations regarding the adequate disclosure of such important data as sponsors, protocols and results (including clinical study reports) of all clinical trials conducted in their jurisdictions."
European institutions running COVID trials can find pratical guidance for managing trial registry data and uploading trial rfesults onto EudraCT on the TranspariMED website.
Please click here to access TranspariMED’s full report including the complete list of all 118 COVID drug trials registered in Europe.