Europe’s academics fail to report results for 90% of clinical trials

Andy · Sep 16, 2018 at 11:06 AM

European academics are failing abysmally when it comes to reporting the results of clinical trials, a study has revealed.

An analysis of data from the European Union’s Clinical Trial Register — published in The BMJ1 on 13 September — shows that around 50% of the listed trials have not complied with guidelines that say results must be reported within 12 months.

The researchers who conducted the analysis found that only 11% of trials run by academic centres — such as those led by universities, governments, hospitals or charities — had published outcomes after completion (see ‘Failing to comply’').
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https://www.nature.com/articles/d41586-018-06676-8

Sly Saint · Sep 16, 2018 at 11:50 AM

in the article there is a link to EU trials tracker: http://eu.trialstracker.net/

About the EU Trials Tracker
Non-reporting of clinical trial results is an ongoing global public health problem.

The best currently available evidence shows that around half of all trials go unreported: this means that doctors and patients see only a partial, biased fraction of the true evidence. We cannot make informed decisions about treatments unless all the data is reported. Under EU rules, from December 2016, all trials on the European Union Clinical Trials Register (EUCTR) should post results within 12 months of completion. There has never been a rule as simple and clear as this, anywhere in the world. Our EU Trials Tracker shows which organisations are compliant, and which aren't. Our paper in the BMJ analysed the data as of January 2018, and found that only 49% of Europe's clinical trials reported results in the register.

This website is one of a series of Trials Trackers produced by the EBM DataLab at the University of Oxford.

What is a Clinical Trial?
Clinical trials are the gold standard in medicine: they are the most fair test of whether a treatment really works; they are also used to assess how one treatment compares to other available options. In a clinical trial, the treatment is usually given to real patients, in a real-world setting. The outcomes measured are ideally real-world problems that matter to patients, such as pain, disability or death; but can also include lab tests, or scans.

Why Do We Need All Trials Reported?
We use the results of clinical trials to make real-world decisions about which treatments work best. We can’t make informed choices if the results of clinical trials are withheld from doctors, researchers, and patients.

Where Can I Read the Journal Paper About This?
Full details of our research is published in the academic paper "Compliance With Requirement to Report Results on the EU Clinical Trials Register: a Cohort Study and Web Resource" by Ben Goldacre, Nicholas J DeVito, Carl Heneghan, Francis Irving, Seb Bacon, Jessica Fleminger, Helen Curtis and Open Knowledge International. This is a long and detailed analysis that describes the background and implications of the data at length, gives technical information about our methods, and reports further statistical analyses such as factors associated with reporting, or not reporting, trial results.

Who Made the EU Trials Tracker?
The Evidence-Based Medicine Data Lab at Oxford University: we are a truly multi-disciplinary team of clinicians, academics, and software engineers working together to make data more impactful in the real world. Francis Irving was the software engineer for the site; Ben Goldacre was the principal investigator; Nick DeVito was the researcher.
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eta: can't find Bristol Uni

Trish · Sep 16, 2018 at 11:54 AM

This article is based on a paper by Ben Goldacre:

Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource
BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3218 (Published 12 September 2018)Cite this as: BMJ 2018;362:k3218

Ben Goldacre, senior clinical research fellow1,

Nicholas J DeVito, researcher1,

Carl Heneghan, professor2,

Francis Irving, software engineer1,

Seb Bacon, lead software engineer1,

Jessica Fleminger, research student1,

Helen Curtis, researcher1

Accepted 16 July 2018

Abstract
Objectives To ascertain compliance rates with the European Commission’s requirement that all trials on the EU Clinical Trials Register (EUCTR) post results to the registry within 12 months of completion (final compliance date 21 December 2016); to identify features associated with non-compliance; to rank sponsors by compliance; and to build a tool for live ongoing audit of compliance.

Design Retrospective cohort study.

Setting EUCTR.

Participants 7274 of 11 531 trials listed as completed on EUCTR and where results could be established as due.

Main outcome measure Publication of results on EUCTR.

Results Of 7274 trials where results were due, 49.5% (95% confidence interval 48.4% to 50.7%) reported results. Trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial 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). More recent trials were more likely to report results (per year odds ratio 1.05, 95% confidence interval 1.03 to 1.07). Extensive evidence was found of errors, omissions, and contradictory entries in EUCTR data that prevented ascertainment of compliance for some trials.

Conclusions Compliance 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.
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Jonathan Edwards · Sep 16, 2018 at 12:15 PM

This is definitely a big problem but may need a pinch of salt. UCL pestered me for about three years for the results of a trial I had told them had never been started and would not be. I am sure it has gone down as an unreported trial.

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