EUTrials Tracker tool data shows that 48.9% of clinical trials should have reported results but have not to do so, only 51.1% of clinical trials reported results. 68% of company sponsored trials have reported results as compared to only 11% of academic trials.
Some pharma companies are reporting all trials with 11 major commercial sponsors achieving 100%, and most pharma companies are reporting above 80%. 32 major academic sponsors had 0% compliance, with most reporting less than 50% of due trials.
Majority of major pharma companies are coming close to complying, with the majority if major academic institutes not according to the report. EU clinical trial rules state results must be reported to the EU clinical trial register for every trial on the register within a year of test ending. Tougher rules are being introduced in 2019, to date no one has ever been sanctioned for breaking European rules.
EU register data was noted to be riddled with mistakes and inconsistencies that could make it impossible for regulators to fully assess compliance for every clinical trial. AllTrials campaign group has been pushing for greater trial transparency saying “there are no excuses for academics’ poor reporting rates.”
Public pressure and ethical need for compliance to trial reporting are hoped to be enough to make all fall in line and comply, but EU Clinical Trial Regulation is coming into force in 2019 bringing with it substantial financial penalties for sponsors breaching compliance of reporting requirements, meaning all trial sponsors including universities must get their files in order now.
Adds Sile Lane, head of international campaigns and policy, Sense about Science says, that the report shows that some are taking the issue seriously, but there is a vast difference from the top to bottom. Many say there is no excuse for failing to report, and questions come into play such as why should institutions be allowed to run another trial while they have not posted results of overdue trials on the register? Why are ethics communities giving them permission and funders paying them?
Clearly something must be done to get companies and academic centers to reach 100% compliance. It was noted that thousands of trials were killed off or completed but not taken into account by the tracker because of dating issues. Noncompliance strikes a blow to the heart of evidence based medicine, resources can be needlessly wasted and informed choices cannot be made regarding which treatments work best unless all results are reported.
