NIHR's draft policy on clinical trial reporting: strong overall, but some gaps remain
UK's National Institute for Health Research has revealed its plans for bringing its policies on clinical trial reporting fully into line with global best practices. NIHR's transparency plans are strong overall, but important gaps remain.
In August 2017, NIHR signed the WHO Joint statement on public disclosure of results from clinical trials, committing itself to adopting global best practices in clinical trial transparency over the following 12 months.
One year later, Transparency International, Cochrane and TranspariMED wrote a joint letter to NIHR urging it to “fully implement” the provisions of the WHO Joint Statement. (See this checklist of best practices.)
Last month, NIHR published a draft “NIHR policy on prospective trial registration and timely disclosure of Clinical Trial results” for consultation.
Below an overview of TranspariMED's take on the NIHR's proposed new policy.
STRONG POINTS
The proposed policy is strong overall, while also being brief and clear:
In future, key outcomes and the trial protocol must be made publicly available within 12 months of trial end.
This marks a huge step forward for NIHR, which already has an outstanding track record in ensuring that outcomes of research it funds are published in journals, but so far has not focused on outcomes reporting in clinical trial registries. The 12 month timeline means that in future, patients and doctors will be able to access the insights generated by NIHR-funded research considerably more rapidly.
Clinical trial registries must be regularly updated.
This is an important issue that many other funders currently ignore. TranspariMED has come across dozens of out-of-date registry entries. This means, for example, that registry users cannot determine whether a trial is still ongoing, making it difficult for patients to locate trials that they can enrol in.
Grant applicants must disclose whether trials they have conducted in the past were registered and reported.
This is excellent, full stop.
REMAINING GAPS
Researchers who have acted unethically in the past will be allowed to run more trials in future.
Failure to register and/or report trials is a clear ethics violation under the Declaration of Helsinki, but the NIHR draft policy only states that "applicants may alternatively comment on why prospective registration and/or publication was not possible". Extending public funding to unethical researchers to conduct new trials involving human participants on the sole condition that they ‘comment’ on their past unethical behaviour is ethically highly questionable.
NIHR should require applicants to retrospectively register and/or post results for all past trials that breached ethical norms, as a condition of receiving a new grant.
NIHR should also take into account the summary results posting performance of the institution at which a grantee is based.
NIHR has not committed to a date for launching its compliance monitoring system.
This falls short of the commitments it made in 2017.
Setting up a monitoring system was a commitment NIHR made over a year ago when it signed up to the WHO Joint Statement. It is disappointing that no such system has yet been put into place. NIHR should now set a target date for its launch.
NIHR only plans to release "summary reports" on compliance.
This falls short of universal transparency and accountability standards commonly applied in democratic societies, as it would hide from the public which researchers have acted unethically and broken the rules.
NIHR should not re-aggregate granular data it holds to shield unethical medical researchers and institutions with weak research integrity safeguards from public view. Monitoring data should be published in line by line format, including the name of principal investigator and the name of the institution involved.
In sum: NIHR's proposed policy is strong overall, but important gaps remain.
NIHR, one of the world's twenty largest non-commercial medical research funders, has long been a global front-runner in clinical trial transparency, to the benefit of UK taxpayers and patients alike. Closing the remaining gaps would cement NIHR's excellent reputation by bringing it fully into line with global best practices.