A new interactive website, eu.trialstracker.net, shows that 49% of clinical trials on the EU clinical trials register have not reported results. EU rules say clinical trial results must be reported onto the EU register for every trial there within 12 months of the end of the trial. Only 51% of trials on the register are currently complying with this. No one has ever been sanctioned for breaking the European rules.
The EUTrialsTracker also shows that European academic institutes are lagging far behind companies in complying with the reporting rules – 68% of company-sponsored trials that are due to report results onto the register have but only 11% of academic trials have. This means that nearly 90% of the trials sponsored by European universities, governments, charities and research centres are breaking EU rules.
There are no excuses for not reporting results
The EU’s rule for reporting results is one of the most straightforward and clearest in the world. There is no excuse for researchers not to comply with it. Nevertheless, researchers continue to make excuses to AllTrials when we ask them why they aren’t reporting. Their excuses don’t add up. To save us time answering another round of excuses today we have gathered here the excuses with some unequivocal answers.
The EUTrialsTracker can produce ranked lists of the trial sponsors who report results for the most and least of their trials.
The EUTrialsTracker currently shows that:
- Eleven major sponsors have reported results for 100% of their due trials. These 11 are all companies.
- All of the major sponsors who have reported results for 90% or more of their trials are companies. There are 31 of them.
- Thirty-two major sponsors have published results for none of their due trials on the register. All 32 are European hospitals, universities and research institutes.
- All the major sponsors who have reported results for less than 10% of their trials are non-commercial entities. There are 42 of them.
- Looking beyond major sponsors to the thousands of organisations who have even one trial on the register, some non-commercial organisations have achieved compliance with the reporting rules. For example the UK medical research charity Cancer Research UK currently has only three due trials on the register but has reported results for all three of them.
Researchers at the DataLab at the University of Oxford built the EUTrialsTracker. They describe how they made it and an analysis of some of the data produced by it. See their paper published in the BMJ.
Why should rule breaking institutes be allowed to continue running trials?
Síle Lane, head of international campaigns and policy, Sense about Science, said
“The new tracker shows us that some companies and universities are taking this issue seriously. But there’s a vast difference between the best and the worst. There’s no excuse for failing to report results.
So, why should Helsinki University be allowed to run one more trial, while they have not posted results for any of their 12 currently overdue trials? Or the University of Nottingham, which has reported results for just 1 out of their 17 overdue trials on the register?
Why should these institutions be allowed run any more trials on patients? Why are ethics committees giving them permission to run more trials? Why are funders paying for them?”
Dr Ben Goldacre, Director of the DataLab at the University of Oxford, and lead author on the BMJ paper, said:
“This problem strikes to the heart of evidence based medicine. We cannot make informed choices about which treatments work best, as doctors and patients, unless all results are reported.
We hope that our data will help trial sponsors to move fast and get their houses in order. We have identified the individual non-compliant sponsors, and trials, in order to help them do so.
We would hope that public pressure and the ethical need for trial reporting should be enough. But the EU Clinical Trials Regulation is coming into force next year. It will bring substantial financial penalties for sponsors in breach of reporting requirements. All trial sponsors – especially universities – must get their house in order now.”
The current rules on reporting results are straightforward and clear
In 2012 the European Medicines Agency (EMA) which oversees the EU Clinical Trials Register and medicines regulation in the EU announced the new rule stating that results must be reported on the register. Clear deadlines were set for reporting – one year from the end of the trial for most trials, and within six months of completion for trials involving children. After various delays, the final date for sponsor’s compliance was 21st December 2016.
The EU rules are clear that results must be posted directly onto the EU trials register. This is with good reason. Reporting on a register has several advantages over academic journal publication: it is much easier to locate results; it is much easier to track compliance; and registers mandate important information that must be included in the results report. By contrast, there is extensive evidence to show that results reports in academic journals are incomplete, of poorer quality than registry reports, and less complete on important issues such as adverse events data.
Why hasn’t anyone been sanctioned for breaking the rules?
Under EU rules the EMA is required to publicly flag any trial that is overdue and contact the sponsor. But there is no flagging of overdue trials on the EU register, and to our knowledge no trial sponsor has ever been contacted over non-compliance. We hope the EMA will now explain why they have not done so.
The researchers did find that the data on the EU register is so riddled with mistakes and inconsistencies that it is probably impossible for the European regulator to fully assess compliance for every clinical trial.
Fergus Sweeney, Head of Inspections, Human Medicines Pharmacovigilance and Committees at EMA said today:
“We welcome the publication of this study. It is a very good example of how transparency can support public scrutiny and enable the development of tools to support that.
We need to reflect on how we can improve our communication with academic sponsors and smaller sponsor organisations. This study helps to spread the word on how important it is to post trial results once a clinical trial is over. We at EMA are firm believers that transparency and public availability and scrutiny of clinical trial information and results are fundamental for the protection and promotion of public health.”
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- European Commission guideline (2012/C 302/03) Guidance on posting and publication of results-related information on clinical trials in relation to implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006. Section 4.7 specifies EMA’s role in publicly flagging overdue trials.
- https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001566 (Specifically makes adverse events claim) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4650202/ (Outcomes are discrepant b/w registry and journal outcomes)