UK government promises national strategy to boost clinical trial reporting
A national clinical trial transparency strategy will be published before the end of this year, the UK government has announced.
The statement marks a significant step towards ensuring that all clinical trials conducted in Britain are registered and publish their results.
Hidden clinical trial results harm patients and undermine public health. Click on the presentation below to see how 33 negative trials of antidepressant drugs disappeared from public view:
The new strategy is expected to include central monitoring of all clinical trials conducted in the UK to check if they were registered and reported.
Norman Lamb MP, chair of parliament's Science and Technology Committee, called on the government to rapidly commit funding for the monitoring scheme:
“While we welcome the government’s response, it is disappointing that four months after our report was released, we still don’t have any confirmation of the additional funding needed to support the Health Research Authority (HRA) to implement our recommendations. The Committee remains hopeful that a decision will be made on funding for audits of clinical trials reporting before we return to this issue after the summer."
The AllTrials campaign also urged the government to commit funding, pointing out that the resources required "will be a drop in the ocean of the costs of repeated and pointless trials.”
Institutions that fail to comply may face sanctions. Director of Transparency International Health Initiative, Rachel Knowles said:
“History indicates that if patients and funders are to get the disclosure they deserve and need, sanctions will ultimately be necessary. We hope the Health Research Authority will keep this option on the table.”
The government’s announcement comes in the wake of a 2018 parliamentary enquiry into unreported clinical trials. After discovering that numerous UK universities and NHS Trusts –public bodies – are routinely violating European Union disclosure rules, parliament called on the government to impose “tough sanctions”.
Norman Lamb MP, who led the enquiry, has recently written to over forty universities to prompt them to post missing clinical trial results on to the European registry.
NHS Trusts across the country will soon receive similar letters from Mr Lamb. The letters warn institutions that if they have not cleared their backlog of unreported trials by the end of summer 2019, they may get called before his committee to explain themselves.
Chair of HealthWatch, Professor Susan Bewley said:
“Patients who volunteer for research, and all those in the institutions performing and supporting research, deserve reassurance that all trials are fully and fairly reported without outcome switching - so that all their efforts will help others in the future.”
A report published by TranspariMED and UAEM in January showed that UK universities have failed to post the results of 254 clinical trials onto the European registry, and have left 1,624 more trials unreported on the American registry.
The EBM Data Lab recently found that NHS Trusts have failed to post the results of at least 170 trials.
These figures considerably underestimate the true scale of underreporting because many trials that were completed long ago are falsely marked as “ongoing” on the European registry. The UK medicines regulator (MHRA) has recently begun updating the status of long-completed trials to improve the quality of this data.
Some UK universities and NHS Trusts have already started posting missing trial reports.
King’s College London has by now posted the results of 96% of its trials onto the European registry, and several NHS Trusts have already achieved reporting rates of 100%. Freedom of Information requests filed by TranspariMED indicate that many institutions are aiming to clear their backlogs before the summer deadline set by parliament.
Founder of TranspariMED, Till Bruckner said:
“Patients and medical researchers should welcome parliament's strong engagement. We will keep a close eye on how the monitoring system is designed, and will keep pushing for effective sanctions including fines. Institutions conducting medical research must not be allowed to remain above the law.”
Some European universities are also working to address the problem, but progress on the continent is far slower. Here the current reporting rates of the five universities sponsoring the largest numbers of trials in Europe:
Copenhagen University (Denmark) 8%
Medical University of Vienna (Austria) 6%
KU Leuven (Belgium) 13%
Karolinska Institutet (Sweden) 0%
Radboud University (Netherlands) 33%
(Visit the EU Trials Tracker website to discover the reporting rates of your local university.)
Under European Union guidelines, clinical trials listed on the European trial registry must post their results there within 12 months of trial completion. These guidelines will become a binding regulation in late 2019 or 2020; individual member states will be responsible for enforcing them.
Important clarification:
The government response states that: “In respect of a clinical trial that is under review by peer reviewed journals which prohibit disclosure of results pre-publication, the results will be posted at the time of publication.” This directly contradicts both the EU guideline, which does not allow for such exceptions, and global best practices.
The International Committee of Medical Journal Editors has clearly and explicitly stated that “The ICMJE will not consider as prior publication the posting of trial results in any registry”. Thousands of medical journals follow the ICMJE recommendations (full list here). It is unlikely that any respectable journal would make such a demand in this day and age.
In any case, the interests of patients and the wider public should take precedence over the whims of individual scientists and editors. In line with global best practices, institutions should ensure that the summary results of each and every clinical trial are posted onto a public registry within 12 months of a trial’s primary completion date, irrespective of academic publication status, and irrespective of whether a trial is covered by EU guidelines or not.
The government’s formal response to parliament can be found here. A separate response by the Health Research Authority is here.