Month: 16 Apr 2019
Issue: not yet available
The EU Clinical Trials Register (EUCTR) indicates that the compliance with the EU rules “have been poor overall”
A new automated tool, the “EU TrialsTracker”, has been launched by several academic researchers working at the Evidence-Based Medicine Data Lab, University of Oxford, UK. The tool provides an automated software algorithm designed to identify commercial and non-commercial clinical trial sponsors with the best and worst record for sharing trial results. The underlying premise is that a failure to publish clinical trial results leads to a publication bias, which the authors argue harms patients, researchers and doctors, and ultimately harms clinical care. The initiative is supported by the Laura and John Arnold Foundation to conduct work on research integrity.
The tool, available at https://eu.trialstracker.net/, ranks trial sponsors, both industry and academic, who fail to publish their research results following completion of clinical trial studies. Failure to publication leads to issues of “missing data” which may lead to direct harm to the patient and specific examples of such harm are well document by one of the tool’s designers, Dr. Ben Goldacre. According to Dr. Goldacre, “[c]ompliance with the European Commission requirement for all trials to post results on to the EUCTR within 12 months of completion has been poor, with half of all trials non-compliant. EU registry data commonly contain inconsistencies that might prevent even regulators assessing compliance. Accessible and timely information on the compliance status of each individual trial and sponsor may help to improve reporting rates”.
The Evidence Based Medicine (EBM) lab at the University of Oxford tracks interventional studies registered at the European Medicines Agency database with a status of either “completed”, or with a completion date more than 12 months ago. According to the collected data there were 7,274 trials where results were due, but just below 49.5% of results were not yet reported (95% confidence interval 48.4% to 50.7%). Interestingly, trials with a commercial sponsor were “substantially more likely to post results than those with a noncommercial sponsor (68.1% v 11.0%, adjusted odds ratio 23.2, 95% confidence interval 19.2 to 28.2); as were trials by a sponsor who conducted a large number of trials (77.9% v 18.4%, adjusted odds ratio 18.4, 15.3 to 22.1)”. The study of the under-reporting showed that the EBM lab has the first study of compliance with European Commission requirements on trial reporting. Unfortunately, EU universities fared very poorly compared to commercial sponsors and perhaps the poor performance may be due to inefficiencies, to a lack of resources, staff training, and including that some researchers “may be more likely to be unaware of their obligations or lack administrative procedures”. Regardless, “in law, the sponsor is responsible for reporting the trial on to the register”, and therefore a failure for a sponsor to report studies, within 12 months of completion, is commonly being breached. It is now important to police this system in order to ensure that there will be necessary benefits for patients and clinicians.Back to previous