Belgian drug regulator under fire for inaction on missing clinical trial results
Belgium's national medicines regulator AFMPS is failing to keep data on drug trials up to date and turning a blind eye to widespread violations of transparency rules, a new report published today suggests.
Three Belgian patient and health groups working with TranspariMED found that dozens of drug trials involving Belgian patients are missing results in clear violation of long-standing European reporting requirements, leaving potentially dangerous gaps in the medical evidence base.
The true number of missing results is likely to be in the hundreds, but cannot be precisely determined because the Belgian regulator has neglected to keep trial data on the European registry up to date.
Several institutions noted that they had asked AFMPS to change incorrect data on the trial registry, but that AFMPS had not always followed up, leaving completed trials falsely marked as ‘ongoing’. AFMPS did not respond to an invitation to explain how it intends to improve trial reporting and data quality going forward.
On the positive side, two leading Belgian institutions have significantly improved their clinical trial reporting performance in recent months.
KU Leuven, a large medical university, and the European Organisation for the Research and Treatment of Cancer (EORTC), have now uploaded results for nearly all their due trials, a remarkable achievement.
Note: The chart above illustrates how difficult it is to assess how many due clinical trials are really missing results. Université libre de Bruxelles has run 99 trials, but only 7 of those are marked as completed – and none has results. However, the university has almost certainly completed more than 7/99 trials, so the true number of overdue results is likely to be far higher.
Other non-commercial sponsors have made little or no progress despite having been notified of their weak performance many months ago. However, most Belgian institutions now say that they plan to fix the problem.
In a joint statement, the three Belgian groups – Kom op tegen Kanker, Test Achats and Cochrane Belgium – demanded immediate action from universities and AFMPS:
“We demand that universities immediately fulfil their obligation to report the results of clinical trials on EudraCT [the European trial registry]. We also demand that AFMPS meets its responsibilities to update the status of clinical trials, and support, monitor and if necessary sanction trial sponsors. [In addition] research funders must stimulate investigators and universities to comply with their reporting obligations.”
“Failures to report trial results are a sign of disrespect towards trial participants. It is thanks to these individuals that doctors can better decide which medicines are the best for their patients.”
“We will publish an update report six months from now.”
In a separate development, 18 health groups today called on national regulators across Europe to take action and ensure that the results of all clinical trials are made public as rapidly as possible. More than 4,000 drug trials are currently missing results on the European trial registry.
The full Belgium report (in English) and press release (in French) can be downloaded below.
Report (in English):
Press release (in French)