Smoke and mirrors about clinical trial transparency at UK parliamentary inquiry
Recent submissions of evidence to UK parliament's Science and Technology Committee's ongoing inquiry into research integrity provide an interesting case study in political smoke and mirror dynamics.
The Committee has been examining why many clinical trials conducted in the UK still fail to register and to post summary results on trial registries, despite compelling ethical, scientific, fiscal, and public health reasons to do so, not to mention the existence of relevant national and European regulations, and a previous inquiry into the same topic by the very same Committee (whose recommendations were subsequently largely ignored).
Three submissions recently received by the Committee illustrate the bureaucratic inertia that elected representatives have to contend with as they seek to safeguard patients' and taxpayers' interests.
Update 27 June: TranspariMED has just provided additional written evidence to the SciTech Committee to explore the policy implications of the developments discussed below.
The letter highlights the Medical Research Council's strong commitment to transparency and related actions. However, the letter fails to mention that the MRC in 2017 signed up to the WHO Joint Statement on clinical trial transparency, committing itself to putting into place strong integrity safeguards and mechanisms within a year.
Over a year later, according to preliminary data compiled by Dr Ben Goldacre's EBM Data Lab, the MRC has failed to honour many of its transparency promises:
only 3/5 promises on trial registration kept
only 4/5 promises on results reporting kept
The MRC is indeed a leader in clinical trial transparency in global comparison, and deserves praise in this regard, but nonetheless still has a considerable distance to go.
In particular, the MRC has not audited grantees' maintenance of trial registry entries or their posting of summary results onto registries, despite the fact that it explicitly committed to doing so over a year ago when it signed the WHO Joint Statement.
The Russell Group, which represents 24 research intensive UK universities, shared the "Russell Group Statement of Cooperation in respect of cross-institutional research misconduct allegations".
Whatever the merits of that statement, it is striking that in a submission to a parliamentary inquiry that has devoted considerable attention to looking into the generally dismal performance of UK universities in terms of clinical trial transparency, the Russell Group not once mentions clinical trials.
The Russell Group has failed to even vaguely commit to getting future trials reported on time, let alone to preventing the results of hundreds of older clinical trials from being lost forever. These trials typically involved UK patients and were funded by UK taxpayer money.
The Russell Group's submission underlines that voluntary action by universities alone is highly unlikely to result in all university-sponsored trials getting registered and reported.
Item 3: Letter from Sam Gyimah MP, Minister of State for Universities, Science, Research and Innovation
The Minister's letter combines the worst of the two preceding submissions.
First, it highlights the strong commitment of transparency by the MRC. It then notes that in February 2018, "the MRC wrote individually to all lead investigators for clinical trials awards and highlighted that a further audit of publication would be undertaken", which is fantastic news and a great step forwards.
However, it fails to dicuss MRC's track record in ensuring that summary results are posted onto registries (currently unknown, due to a lack of relevant auditing; see also above). Worse, it states that
"Certainly, more emphasis should be placed on timely publication (within 2 years)..."
In fact, WHO best practices - which the MRC voluntarily signed up to in 2017 - clearly state that trial results should be shared on trial registries within 12 months, not two years.
This 12 month time frame for disclosure of trial results is a widely accepted global standard also reflected in EU regulations and US legislation, and has been explicably embraced by Transparency International, Cochrane, and the AllTrials campaign.
Like the Russell Group, the Minister for Universities fails to even allude to the performance of universities, which do a far, far worse job at publishing trial results than the MRC does.
Finally, the letter states that:
"In terms of the resource costs required for the HRA to carry out an audit and chase up publications, I have not had a request for funding from the HRA. However, the MRC have devoted significant dedicated staff resources to find and analyse the data on MRC-funded clinical trials. The MRC will be able to share this experience with HRA via its representative on the HRA Transparency Forum which is a forum for funders, registries and regulatory bodies to share information and good practice on research transparency."
In fact, the HRA already has the know-how required to conduct a trial audit - it's not rocket science, the HRA itself has already conducted a partial trial audit in the past, and audit pioneers Dr Simon Kolstoe and Dr Ben Goldacre have explicitly offered the HRA technical support for any future auditing work
The real question is whether the HRA will receive political steer to create a National Clinical Trial Audit System, plus the (very limited) funding it would require to set it up.
Postscript
None of the submissions mentions that under United States law, trial sponsors who fail to post summary results within 12 months face an $11,000-a-day fine.