Drug companies have taken a lot of heat over the years for not promptly reporting results from clinical trials, but a new study suggests academics may be even worse. Nearly nine in 10 university clinical studies fail to report results in the European Union Clinical Trials Register (EUCTR) within the required 1-year time frame, a team from the Evidence-Based Medicine DataLab at the University of Oxford in the United Kingdom reports today in The BMJ.
Sharing the methods and results of all trials is “an ethical and scientific imperative,” the authors say. EU guidelines require that results be published in the EUCTR 12 months after a registered trial ends, but there is no legal basis for the European Medicines Agency (EMA), which runs the register, to impose penalties on laggards.
Compliance is low across the board and particularly poor at universities. In January, the Oxford team downloaded records for all 31,821 trials registered in the EUCTR since 2004. Overall, about half of the 7274 trials that were due to report results at the time of the study complied, the researchers found. Only 11% of university-led trials in the study complied with the 1-year mandate, compared with 68% of ones run by companies.
Oxford’s Ben Goldacre, who co-founded the AllTrials campaign in 2013 to boost clinical data sharing, led the study. “We hope that our data will help trial sponsors to move fast and get their houses in order,” he said in a statement that also slammed “bad excuses from trialists.” In the same statement, Síle Lane, head of international campaigns and policy at Sense about Science, a charity in London that runs AllTrials, called for clinical trial funders and ethics committees to prohibit noncompliant institutions from running new trials.
The paper lists worst offenders, including the Charité University Hospital in Berlin and the Ludwig-Maximilian University (LMU) Hospital in Munich, Germany, as well as Sweden’s Karolinska Institute in Stockholm. Together, the three centers owed results on 110 trials and had reported none, the paper says. (The reporting data are updated regularly on EU Trials Tracker, a new public website launched by the Oxford team.) In The BMJ study, Goldacre and co-authors also flag “extensive evidence” of missing and contradictory data in EUCTR entries.
The responsibility for reporting results to the EUCTR lies with individual researchers, an LMU spokesperson tells ScienceInsider. They add that the university is planning to put tools in place to help researchers comply with the EU requirements.
A few academic institutions have achieved high compliance rates, in particular the University of Dundee (82% of trials with results reported within 1 year) in the United Kingdom and the University of Oxford (77%).
But reporting tasks “cannot be just thrust on researchers and universities,” says Jacob George, director of R&D at the United Kingdom’s National Health Service Tayside and professor of cardiovascular medicine at the University of Dundee, who is responsible for his institution’s good showing. George says reading about low trial reporting rates in an AllTrials report about 3 years ago prompted him to take action. “I must have spent 100 hours chasing up investigators myself” to tackle the backlog at his university, he tells ScienceInsider. George says he also secured funding for a temporary, half-time employee who will work on internal processes to improve reporting in the long term.
Reporting can be cumbersome, for instance, when a researcher moves to another job after working on a clinical trial. George says researchers also need trial funders to provide funding that matches their declared transparency goals, as well as formal reassurance from journals that posting results in registries does not preclude publication of peer-reviewed articles.
The European Union’s 2014 Clinical Trial Regulation, which comes into effect next year, will tighten requirements for reporting results. The regulation provides a clear legal obligation, rather than mere guidance, and allows member states to lay down rules for penalties in case of infringements.
For now, EMA says it is developing a system to flag overdue trials. “We need to reflect on how we can improve our communication with academic sponsors and smaller sponsor organizations,” says Fergus Sweeney, EMA’s head of inspections, human medicines pharmacovigilance and committees in London. “This study helps to spread the word on how important it is to post trial results once a clinical trial is over.”