In 2013, British MPs demanded greater clinical trial transparency. A sense of déjà vu?
In 2013, the House of Commons Science and Technology Committee published a report on clinical trials concluding that “We consider the current lack of trial transparency to be unacceptable and we have not been impressed by the Government’s efforts to resolve this problem to date.”
The 2013 report reflected an excellent understanding of the problem and proposed several appropriate, feasible, low-cost measures to resolve it. However, four years later, virtually nothing has changed in UK clinical trial transparency.
Below a quick overview of the striking lack of progress since 2013.
2013 report – trial registration:
“We recommend that the Government take steps to ensure that, in future, all clinical
trials conducted in the UK, and all trials related to treatments used by the NHS, are
registered in a WHO-listed primary registry.” (page 36)
Action (not) taken:
The HRA made trial registration compulsory in 2013 but does not systematically monitor or enforce compliance. There are no penalties for non-registration.
A one-off audit conducted by the HRA in 2015 shows that many trials conducted in the UK are still not being registered.
The government has not taken any action to get past trials registered.
2013 report – summary results and academic publication:
“It is also important that summary-level trial results are made public, and we do not accept the argument that it is not possible to publish ‘negative’ results in peer reviewed scientific journals. We recommend that trial registration and publication of summary-level results be made contractual requirements for all publicly-funded trials, including those covered by the Charity Research Support Fund.” (page 3)
Action (not) taken:
Contractual requirements lack teeth if compliance is not being monitored. In 2017, the NIHR and MRC signed up to a new WHO initiative, pledging that they will audit grantees’ reporting performance and publish audit results within a year. This is great news and fully in line with a recommendation recently made by Transparency International, but we’ll have to wait until 2018 to see if they deliver on their promises. (TranspariMED will keep an eye on this.)
AMRC have not yet signed up to the WHO initiative.
2013 report – Clinical Study Reports:
“CSRs [Clinical Study Reports] can make a useful contribution to the scientific literature. Once a regulatory decision has been reached, there is no compelling reason why CSRs should not be placed in the public domain, with identifiable patient data redacted.” (page 41)
Action (not) taken:
The UK government has taken no action to get CSRs into the public domain. For example, the NHS continues to pay for drugs whose CSRs remain hidden away.
The European Medicines Agency began proactively releasing some CSRs in 2016, but this European policy does not cover CSRs for most drugs currently being prescribed in the UK.
Post-Brexit, scientists based in the UK may have difficulties accessing even the small sub-set of CSRs released by the EMA.
2013 report – retrospective audit of public grants:
“We therefore recommend a retrospective audit of all public phase III trial grants awarded since 2000, followed by action to ensure that any failures to register or publish the summary-level results of these trials are rectified within 12 months. Any failures to correct these mistakes should be taken into account when considering future grant applications from principal investigators of previously unregistered or unpublished trials.” (page 49)
Action (not) taken:
The government never acted on the (excellent) recommendation to conduct a retrospective audit of all large public grants.
2013 report – HRA to monitor and enforce compliance:
“Research Ethics Committees should have a role in considering and monitoring compliance with transparency policies. We recommend that the HRA… ensures that all trials have been registered and published according to an agreed timeline, rather than performing checks on a sample basis. In addition, there must be penalties for non-compliance.” (page 53)
Action (not) taken:
The HRA does not systematically monitor compliance with its transparency policies, and does not impose penalties for non-compliance.
So little has changed since the last inquiry that the SciTech Committee could copy and paste this 2013 text straight into its forthcoming 2018 report:
“Today, many of the clinical trials taking place in the UK remain unregistered and unpublished and their data continue to be unavailable to both the general public and the scientific community. This is unacceptable and we have not been impressed by the Government’s efforts to resolve this important issue.
Until recently, the Government has apparently been content to leave it to other groups at the national, European and global level to lead the way in tackling the problem of trial transparency and, while UK initiatives alone cannot solve what is a global problem, we do not accept limited jurisdiction as a legitimate excuse for Government inaction. We call on the Government to take decisive steps, as outlined in this Report, to ensure greater transparency in all future trials conducted in the UK, in order to demonstrate to the rest of the world how effective solutions might one day be applied at a global level.”
To finish on a positive note, here’s a fun fact: the 2013 report mentioned “transparency” 338 times.
For concrete policy options to get all trials registered and reported in the UK, please see this piece by TranspariMED and this study by Transparency International and TranspariMED.