UK regulators cooperate to boost clinical trial reporting
Key players in the UK medical research system are stepping up their efforts to ensure that all clinical trial results are rapidly reported.
Below some highlights from a recent conference:
UK medicines regulator: Make trial reporting compulsory
The new, post-Brexit, medicines regulator continues to send reminders to researchers to make the results of older drug trials public on the European trial registry as required by MHRA.
Current compliance by UK sponsors is a high 85%, but the MHRA continues to aim for 100%. The Good Clinical Practice (GCP) Inspectorate within MHRA is notified when sponsors fail to upload results.
The MHRA recently concluded a consultation on making reporting of trial results within 12 months of trial completion compulsory under UK law.
The MHRA is also considering introducing sanctions for non-reporting, and making the involvement of patients and the public in the design of clinical trials a legal requirement.
Going forward, the MHRA will work to align trial registration forms with those required by the HRA and the ISRCTN, hopefully making the process easier and less time-consuming for researchers. MHRA noted that the close collaboration of the MHRA with the HRA, NIHR and NHS really added value during the UK’s widely praised Covid-19 clinical research efforts.
UK ethics regulator: Register trials automatically
The HRA has made impressive progress on the UK’s national #MakeItPublic strategy, which aims to ensure that all clinical trials are registered and reported (see the full strategy report and implementation plan).
From January 2022, in partnership with the London-based globally recognised clinical trial registry ISRCTN, the HRA will automatically register all UK drug trials as part of the study approval process. The process will later be rolled out to cover all interventional trials.
The HRA has already developed clear guidance for researchers and set up a system to monitor whether trial results are made public, which should be within one year of study end. TranspariMED and allied organisations have long called for this initiative, and we are delighted that it is at last being set up. By the end of 2022 trial results should also be appearing on the HRA’s website. For the key milestones see TranspariMED’s report.
The HRA also encourages reporting of results in plain English ("lay summaries"), but this is not mandatory.
Trial registry ISRCTN: Capture more trial data
The ISRCTN trial registry now has a formal partnership with the HRA, which will in effect make ISRCTN the UK’s national trial registry going forward.
ISRCTN launched a new “output table” in 2019, allowing those running trials to share a wealth of information on the registry, including statistical analysis plans, preprints, funder reports, and links to external platforms.
ISRCTN will continue to develop its existing system of using email prompts to remind researchers to update registry data and upload trial results.
UK research funder: Open access = 100%
In November 2021, the National Institutes for Health Research (NIHR) published a new Open Access policy that will require all peer-reviewed research articles arising from NIHR-funded research studies immediately to be made open access under an open licence.
This means that the published results of research funded by UK taxpayers and others will be available to read online for free. This change will apply to all peer-reviewed articles submitted for publication from June 2022.
UK charity: Communicate with research participants
An excellent new communications toolkit developed by Parkinson’s UK deserves to be adopted by all research funders in all areas of health research – possibly even as a condition of receiving funding.
What’s ahead in 2022?
TranspariMED and allied groups will keep an eye on the new developments as they are being implemented in 2022.
Below the HRA’s timeline for implementing the national strategy (more details here):
Why is this so important?
Clinical trial transparency is not about adding bureaucracy and hampering innovation, it is about protecting patients and the quality of research.
Registering clinical trials publicly, even before they start, helps other scientists discover who is currently researching which treatments, preventing needless duplication of medical research efforts.
Wasted research comes at mind-boggling financial and also human costs, as patients in clinical trials may be subjected to unnecessary risk. And by requiring investigators to declare publicly at the outset what their study will be measuring, it is harder to manipulate the resulting data at a later stage, either to distort the evidence or for financial gain or glory.
Note: This blog is an abridged and slightly edited version of a newsletter article originally published by HealthSense UK, a charity that TranspariMED routinely cooperates with. The article was largely based on proceedings of the HRA’s November 2021 Make It Public conference, and was jointly written by Till Bruckner, TranspariMED; Caroline Struthers, UK EQUATOR Centre; Mandy Payne, HealthSense Newsletter editor. Images are screenshots of conference presentation slides.