Experts call for audits of clinical trial reporting performance in the UK

27 Mar 2017

What practical steps can the UK take to make evidence-based medicine a reality? How can we get all trials registered and fully and accurately reported? Here are some useful ideas, culled from recent submissions of evidence to the House of Commons’ inquiry into research integrity.

 

 

Ben Goldacre:

“A national programme of audit”

 

"Neither soft ‘culture change’ interventions nor legislation have been effective to date… There are innumerable regulations, edicts, reports, guidelines, and strategy documents around trial reporting. None have been enforced or implemented, and breaches are not documented. This creates a dual burden: it creates the illusion that problems have been fixed, when in reality they are ongoing, and so removes the sense of urgency around improving standards, leaving a false sense of reassurance.

 

The government could and should simply require all UK research funders to publicly declare all trials they have funded, and whether those trials have published their results, with performance statistics reported, and all individual reported and unreported trials identified. Several funders committed to produce summary statistics on the proportion of trials reported, among those they have funded, at this Committee’s previous inquiry into non-publication of trial results. To my knowledge, four years later, none of these audits have been made publicly available.

 

The government could also require all ethics committees to generate data on non-reporting with no great increase in administrative burden. At present, all trials in the UK need to be approved by an ethics committee. Currently ethics committees approve research, and then effectively lose contact. The government could simply require all ethics committees to request an end of study report on all approved trials, and publicly disclose whether each study is reported… Overall, we should have a national programme of audit on all clinical trials conducted in the UK, and report performance on whether trials are reported, broken down by institution, funder, researcher, disease area, and so on. This could be conducted by institutions, or ideally independently.

 

It is worth noting that many US universities now have staff nominated to work on ensuring that all trials are registered, with their results reported within 12 months of completion. These staff take responsibility for monitoring compliance, and supporting researchers who require assistance. They are organised under an umbrella organisation: the 'Clinical Trials Registration and Results Reporting Taskforce.' The government should require UK universities and funders to replicate this model.

 

The UK government should require that all trials conducted in the UK are registered, and their full methods and results publicly reported. There is new EU legislation requiring this, but only for drug trials, and the UK is leaving the EU."

 

 

AllTrials campaign:

“Audit registration and reporting, including for past trials”

 

"That the committee recommends that the government supports widespread auditing of clinical trial registration and reporting. Auditing is a recognised tool to drive up performance in medicine. It can uncover good practices that can be shared across sectors. Audits of clinical trial registration and reporting are possible to do, even for past trials. [Goes on to cite two examples of audits: The UK’s Health Research Authority and two Oxford research centres.]

 

That the committee recommends that UK clinical trials law continues to reflect the EU Clinical Trials Regulation after the UK exits the EU… [lists key points of EU regulation] The government should commit to retaining the clauses on clinical trial transparency in UK law after the UK exits the European Union."

 

 

TranspariMED:

“Assume political responsibility for solving the problem”

 

"So far, the systematic distortion of evidence generated by clinical trials has been largely framed as a technical issue, rather than as a political issue. Globally, much of the positive change in the field has been driven by non-governmental players… In a modern democracy, democratically elected representatives cannot abdicate responsibility for removing a clear and ongoing threat to citizens’ health and wealth.

 

The Science and Technology Committee should… issue an unequivocal statement that evidence distortion in medical research is a political issue that requires political action, commission a study providing a quantitative estimate of both the health and financial costs to British citizens of evidence distortion in medical research, [and] commission a study on the legal and regulatory measures required to ensure that all clinical trials are registered and that all results and methodologies are fully reported."

 

 

 

Simon Kolstoe, Samantha Trace and Daniel Shanahan:

“Fund monitoring by the Health Research Authority”

 

"Recently calls have been made for sponsors and funders to audit their research and ensure that data is being suitably published. Whilst this is undoubtedly important, we argue that research ethics committees are in a far better place to determine whether research is being published, and whether the published outcomes reflect the original research.

 

In the UK it is a requirement for researchers intending to conduct many types of human research to submit their protocols for review by National Health Service research ethics committees. In England, there are sixty-eight research ethics committees overseen by the Health Research Authority who, as the national ethics regulator, have access to all the significant, and currently confidential, research protocols. The Health Research Authority is therefore in the best position to support research ethics committees in monitoring publications arising from projects, and determine whether publications accurately reflect the outcomes originally described in research protocols.

 

In a pilot experiment, one of us analysed projects submitted to the Hampshire A REC to determine whether it was feasible to use these records to monitor publication rates… This pilot work demonstrated that those with access to REC records are in a particularly powerful position to detect publication and reporting bias in contrast to similar attempts conducted by research funders or systematic review organisations who do not have immediate access to such a wide range of otherwise confidential protocols.

 

Provisions for audit are already contained in the declaration signed by investigators when they submit their projects for ethical review, and a combination of the electronic submission system (IRAS) and internal HRA databases, ensure that this data is readily available to those with the appropriate permissions."

 

 

 

Note on methodology: I scanned all submissions made to the enquiry for the word “trial” and excluded submissions that did not include this term. I then reviewed the remaining submissions and extracted only those submissions that contained ‘big’ or new ideas for solving the problem of missing clinical trials and evidence distortion in medical research. Hence, many interesting submissions providing detailed problem analyses and/or centring on existing solutions such as the CONSORT reporting standard are not referenced above.

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