UK clinical trial transparency system to go live in 2022
The UK’s strategy to ensure that all clinical trials are registered and their results made public will be (nearly) fully implemented by the end of 2022, the Health Research Authority announced today.
The #MakeItPublic strategy was initially developed in response to a 2018-2019 parliamentary enquiry into clinical trial transparency, which lambasted persistent gaps in trial registration and reporting that waste public money and threaten patients’ health.
KEY MILESTONES NEXT YEAR
The UK Health Research Authority leads the implementation of the strategy, and aims to put most elements into place by the end of 2022:
See here for the detailed implementation plan.
Starting in 2022, the HRA will publish annual monitoring reports to track transparency performance across the sector, including timely clinical trial registration and results reporting.
PROGRESS TO DATE
TRIAL REGISTRATION
A new system has been designed that will ensure that all UK clinical trials are registered on the global ISRCTN registry as soon as they receive ethics approval. Registration will be managed centrally, and will thus reduce the burden on trial managers. This service will be free of charge.
The system is currently being piloted. In early 2022, the first phase will go live, covering clinical trial of medicines. Later, the system will be rolled out to cover all trials.
RESULTS REPORTING
The Health Research Authority (HRA) has strengthened and improved its guidance to researchers so that they are clear about results reporting requirements from the very outset of a study. It has also put into place a system through which researchers have to report a standard set of information at study end, including a confirmation that the results have been published. This will form the basis of HRA’s future monitoring efforts.
According to the HRA:
“We’re now working with the Medicines and Healthcare products Regulatory Agency [UK medicines regulator] on how we can share information about the summary of results we collect in our final reports. As both organisations ask about summary of results, we want to reduce reporting burdens for sponsors and share data and knowledge in order to further the transparency agenda.”
“Next, we’ll use our records to follow up with studies that have not yet submitted their end of study information to us, and in the future we’ll use this to make it clear when studies have unreasonably failed to report on time.”
INFORMING RESEARCH PARTICIPANTS OF FINDINGS
The HRA now asks researchers exactly how and when they will share results with participants, and has developed an e-learning module to help researchers write plain language summaries. Such lay summaries have to be submitted to the HRA as part of the final report, and will be published on the HRA website.
The HRA had previously found that participants of 90% of UK trials were not informed about study results.
HELPING RESEARCHERS TO FOLLOW THE RULES
The HRA has developed a study lifecycle map so that researchers can see at a glance where they need to take action to ensure transparency, as well as other support measures for researchers.
WHAT ABOUT SANCTIONS?
The HRA’s roadmap contains two items related to sanctions:
“Develop a policy for how we will assess performance against research transparency requirements and how that will be used when reviewing new studies for approval.”
“Introduce Research Transparency performance assessment into review of new studies.”
The implementation timeline for both items is open-ended - “March 2022 onwards”.
While UK parliament has repeatedly called for sanctions, the HRA has been historically resistant to move beyond its traditional ‘voluntary compliance’ approach.
An upcoming parliamentary enquiry into research integrity is likely to revisit the issue later this year. TranspariMED will continue to push for sanctions with teeth.
SUPPORT FROM PATIENTS AND INDUSTRY
Matt Westmore, Chief Executive of the HRA, said:
“The #MakeItPublic strategy is not just a strategy for the HRA, it’s a strategy for the whole research community. It was developed with the help of people from devolved nations, industries, funders, charities, academics, researchers, and patient representatives.”
Derek Stewart, patient representative, said:
“Public and patient involvement is essential to clinical research but for this to happen the research studies have to be transparent and easily accessible for the public.”
Jennifer Harris, Head of Research Policy at the Association of the British Pharmaceutical Industry, said:
“ABPI fully supports this vision and will continue to work collaboratively to implement this strategy in order to enhance opportunities for research involvement and improve research transparency.”
Till Bruckner, founder of TranspariMED, said:
“TranspariMED strongly welcomes the scope and pace of the strategy’s implementation. The UK’s national strategy sets the gold standard for clinical trial transparency worldwide. Governments in other countries should put similar transparency mechanisms into place and finally end the ongoing scandal of unregistered and unreported clinical trials.”
According to the HRA progress report published today, “more than one million people took part in COVID-19 studies in the UK in the first year of the current pandemic.”