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Rescuing a hidden trial: patients and taxpayers set to benefit from data brought to light by Transpa

A landmark Freedom of Information request filed by TranspariMED has yielded the first tangible result as a researcher who failed to register a clinical trial has pledged to retrospectively add it to the public record.

“I will working [sic] towards entering the trial onto the website… I will let you know as soon as I have uploaded the data and it’s been approved,” the academic, who is based at Imperial College London, promised.

Unregistered clinical trials undermine the evidence base on drugs and medical devices because they leave the door wide open to evidence distortion. If their results are not made public – which is often the case – they become research waste for the simple reason that nobody can tell that they ever took place. This leads researchers to needlessly duplicate costly trials, and betrays the trust of people who volunteer to participate in trials in order to help advance medical progress.

A few years ago, the UK’s Health Research Authority audited clinical trials conducted in the country during 2013-2015. Despite trial registration being compulsory in the UK, the audit identified 101 trials for which no registration record could be found.

Failure to register trials is a violation of global medical research ethics – and of UK regulatory requirements.

While the audit itself was a welcome step towards greater transparency, the Health Research Authority (HRA) did not publish which trials it had been unable to find registration records for. This lack of line-by-line data prevented independent researchers from checking whether any trials remained unregistered even after the HRA had sent out reminders to the scientists who ran them.

In response to a Freedom of Information request by TranspariMED, the HRA initially declined to release the full data set. The public body released the data set only after TranspariMED requested an internal review and a separate health integrity group, HealthWatch UK, also called for greater transparency.

A member of HealthWatch UK subsequently worked through the data, contacting researchers who may have failed to register their trials.

This is the first trial unambiguously identified as being ‘hidden’. Numerous other trials also appear to have remained unregistered. TranspariMED and the HealthWatch UK member will continue to follow up on these over the coming weeks.

Till Bruckner, founder of TranspariMED, said:

“Hopefully, this trial will now be rescued from the research waste heap. This episode shows yet again how clinical trial transparency directly benefits both patients and taxpayers. The costs of registration and reporting are negligible compared to the millions it typically costs to run a trial. In future, the Health Research Authority should be given the resources required to set up a National Clinical Trial Audit System and ensure that every single trial conducted in the UK is registered and reported.

The Health Research Authority has set a strong positive example by releasing line-by-line audit data. Last year, three other UK public bodies – NIHR, MRC and DFID – committed to auditing their own portfolios of clinical trials during 2018. Building on this precedent, they should publish not just summary data, but the full audit data sets.”

To learn more about the proposed UK National Clinical Trial Audit System, please see TranspariMED’s submissions of evidence to the SciTech Committee, available here.

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