Most EU trial sponsors ‘lack experience reporting results’
Multiple Covid-19 drug trials are being run in Europe by organisations that have previously breached the law on reporting clinical trial results, according to monitoring group Transparimed.
Results of clinical trials in the EU should be uploaded to a central public registry within 12 months of completion, but 39 of the organisations running Covid-19 trials previously failed to comply with this requirement, according to Transparimed.
Another 40 trials are being run by groups that have not had to report trials before, it said on 17 June.
“This means that they may never make the results of their [Covid-19] trials public, especially if the trials showed no benefits from the drugs being tested or got terminated early,” wrote Transparimed founder Till Bruckner.
His group is warning that many of the 118 EU trials of potential Covid-19 treatments risk becoming “research waste” if the results are not made public so they can be used by doctors and researchers.
Of those trial sponsors that do have a track record of reporting, 22 had reported fewer than 50 per cent of due results and nine had reported between 52 and 88 per cent. Only eight were considered by Transparimed to have a strong reporting history, with full or nearly full compliance.
Spain is the country where the largest number of EU-based Covid-19 trials are being run at 48. Of these, 46 trials are run by sponsors who have never uploaded trial results onto the EU registry, according to Transparimed.
France, which hosts the next largest number of EU-based trials at 22, has one trial sponsor with a track record of uploading trial results.
“Lack of transparency in clinical trials reporting continues to be an obstacle to scientific progress,” said Jaume Vidal, a policy adviser at Health Action International. “There is no need for additional obstacles when facing a pandemic of global proportions.”