Clinical trial reporting across Europe could be substantially improved if the EMA fixed problems with its trial registry, a new report launched today by TranspariMED and Health Action International documents.
In many cases, small and uncontroversial technical fixes could make a large difference. For example, the EMA could significantly boost reporting rates simply by emailing reminders to trial sponsors that have failed to post summary results.
Over half of due clinical trials are currently missing results on the EU trial registry.
(This estimate includes the 46% of trials that are verifiably missing results, plus the many completed trials currently falsely listed as still “ongoing” in the EMA-run registry.)
According to best estimates currently available, around half of those trials missing results on the registry have also not reported their results elsewhere either, raising fears about research waste on a massive scale. This widespread violation of EU guidelines leads to the misallocation of public health resources, wastes scarce medical research funds, slows the development of new treatments and cures. In short, it is not in the best interest of patients – or of taxpayers.
Recently, some universities in the UK have significantly improved their performance - largely thanks to pressure by British parliamentarians, by TranspariMED and allied groups, and by the AllTrials campaign - but most of their peers in the UK and other European countries are still routinely violating the rules.
The report shows that in many cases, badly designed processes act as a barrier to full compliance by universities in particular. The EMA can, and must, fix these problems.
In addition, while the EMA has justly been praised for its groundbreaking transparency policies regarding Clinical Study Reports, the release process and approach to redactions currently limit the extent to which these laudable policies translate into greater uptake by, and utility to, the medical research community. Again, these are problems that can be fixed.
The report provides nine actionable policy recommendations for the European Commission, the EMA, and EU national medicines regulators for improving clinical trial transparency.
Over the coming months, TranspariMED in collaboration with Health Action International (HAI) will track the EMA’s progress on the nine action items listed above.