Nearly half of EU clinical trial results are unreported – Quartz

Clinical trials are the cornerstone of medical research. To evaluate the safety and efficacy of new drugs, therapies and treatments, scientists are studying patients in trials that often last for years. In the United States and the EU, researchers have since 2012 reported their results after the end of their trial. But a new BMJ study reveals that 49% of EU clinical trials registered since 2004 have ignored this rule.

There are many reasons why scientists may not follow through on the declaration of their results, the most obvious being the time required. Scientists can instead choose to spend this time writing these results for academic journals, which is far more likely to advance their careers. In addition, there is no penalty for non-compliance; no researcher was sanctioned for failing to file a test report in the EU or the United States.

But there could be serious consequences for patients. The lack of reporting of results could mask crucial information that government agencies and doctors need to make decisions. And as scientists in many fields struggle with replication problems, the results of all trials, even those that have yielded seemingly uninteresting or difficult-to-interpret data, can help researchers determine which drugs or treatments really help the patients.

Six of the seven authors of the BMJ study are members of the Oxford-based medical laboratory, which, together with the new document, has launched the EU's test tracking system. The tracker is a searchable website that seeks to ask investigators to report on their results. Of the 4,891 entities whose trials are subject to EU rules, 104 of them are "major sponsors", which means that they have at least 50 trials underway. Only 11 major sponsors have a compliance rate of 100% and all are companies. In general, lead author Ben Goldacre and his team report that corporate sponsors have a higher compliance rate (68%) than universities, hospitals and research institutes conducting research (11%). ).

Earlier this year, EBM DataLab launched the FDAAA Trials Tracker, a similar site that tracks US test report compliance. The United States only gets slightly better results than the EU: the FDAAA Trials Tracker reports that 59.1% of the trials yielded results and notes that the US government could amass more $ 620 million in fines for non-compliance.

Goldacre and colleagues hope that paper and tracking sites will encourage science agencies to enforce reporting rules. Sile Lane, Head of International Campaigns and Policy for the UK's Sense about Science, thinks there should be repeated consequences. "Why should these institutions be allowed to conduct other trials on patients?", She wrote in a statement. "Why do ethics committees give them permission to do more testing? Why are donors paying for them?