The UK Medical Research Council ensures that all clinical trials it funds are registered and report
The Medical Research Council has revealed details of how it monitors its grantees to ernsure that all clinical trials it funds are registered and report their results.
In doing so, the UK funding institution has essentially produced a detailed how-to manual that should be required reading for other medical research funders worldwide.
In 2017, major medical research funders from around the globe pledged to finally crack down on research waste.
By signing up to the WHO Joint statement on public disclosure of results from clinical trials, over a dozen funders committed themselves to adopting policies to counter reporting bias and curb research waste within a year, and to begin actively monitoring their grantees’ compliance with the new rules.
Not so the Medical Research Council (MRC), which promptly strengthened its policies and started developing a monitoring system to track compliance.
Below five key takeaways from the MRC’s monitoring experiences.
1 The MRC had to draw together data from three internal sources and one trial registry to identify all clinical trials that it had funded.
Data collection was complicated by weak grantee adherence to MRC funding requirements. For example, annual progress reports from grantees usually did not include the required trial registry number. The requirement to register all trials in one particular registry (ISRCTN) was also widely ignored, as was the requirement to identify the MRC as the funder within every registry entry.
The MRC had to contact a third of its grantees directly "one or more times to confirm that a study had progressed beyond the preclinical phase, or to provide registry numbers or publication details.” According to the MRC, its current systems do not allow it to automate the process of sending out such reminders, which made the process labour intensive.
2 Grantees often violated even basic rules
In the UK, medical researchers have had to promise to prospectively register their clinical trial as a condition of ethics approval since 2013. However, during 2014-2015, over a third of MRC-funded trials were still not being prospectively registered. (Compliance with this rule is far better today.) Two thirds of registry entries did not include a link to the trial protocol.
3 Data quality in trial registries is a major problem
Many grantees registered trials in a shoddy manner: “[R]esearchers often provided different information in the registry entry to that held by the funder”. Further down the road, many grantees failed to keep their registry entries up to date. This made it difficult for the MRC to establish whether and when any given trial had ended, and to locate related publications.
The MRC concluded that inaccurate and incomplete registry entries are “a significant cause for concern,” and that more attention needs to be devoted to tackling this widespread problem. (TranspariMED fully supports this view.)
4 Research institutions have to assume responsibility
According to the MRC:
“We also observed that the responsibility for complying with clinical trials transparency requirements falls largely on the shoulders of individual researchers and would therefore strongly endorse the call by Goldacre et al for trial sponsors and research organisations which host trials to take greater responsibility for promoting and monitoring transparency, providing more administrative support, and raising awareness and compliance among researchers."
(TranspariMED strongly endorses this call. Note that US law and EU guidelines clearly identify trial sponsors, not individual researchers, as the parties responsible for registering trials and reporting their results. All universities that have significantly improved trial reporting by their researchers have done so by established some form of central oversight.)
5 A little reminder email can work wonders
The MRC found that contacting researchers who had failed to make their trial results public was a highly effective way of curbing research waste. According to the MRC, such prompts “could be easily integrated into the routine annual review process by funders, registries and regulators.”
(Note: After the European Medicines Agency started sending out reminder emails last year, reporting rates on its trial registry rose steeply.)
MRC's advice to other medical research funders
The MRC identified the following lessons learnt during its monitoring effort:
“(1) developing the use of registry data as a primary source for compliance monitoring
(2) strengthening funder requirements for registry entries to be maintained
(3) improving identification of funded awards that include trials to ensure a complete denominator for evaluating compliance with registration
(4) including the research organisation, registry number and award reference number in compliance monitoring reports to allow further details of individual trials to be found in public registries”
When will other funders follow the MRC’s lead?
Other UK-based funders are also making rapid progress.
The Wellcome Trust has also begun monitoring its grantees and made its monitoring data public.
The UK's National Institute for Health Research (NIHR) has also adopted strong policies and is working on an audit of its own. NIHR grantees who fail to make trial results public already risk losing future funding.
But outside the UK, funders continue dragging their feet.
A recent conversation on the sidelines of a workshop in continental Europe:
Researcher: “I’ve got many unpublished studies in my drawer. I just don’t seem to get around to getting them written up and published.”
TranspariMED: “Don’t your funders mind that you are not delivering anything for their money?”
Researcher: “They don’t monitor that.”
TranspariMED: “Don’t politicians mind that public money is being wasted?”
Researcher: “Oh, they don’t realise that.”
According to the WHO Joint Statement:
“There will be modest costs associated with public disclosure of clinical trial results. The costs of disseminating the results of research are a minor component of the overall costs of conducting such research, and results reporting is an essential component of the research enterprise. The resource allocation, public health and scientific benefits - together with the need to meet ethical imperatives - far outweigh the costs.”
How long will funders outside the UK take to wake up and launch the monitoring efforts they promised us three years ago?
For more details on the MRC’s experiences, please see the paper Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK, published in BMJ Open. The MRC's monitoring dataset is available here.
Funders can use this simple checklist to identify gaps in their current transparency policies.