UK: Despite strong progress on clinical trial reporting, gaps remain
Reporting the results of clinical trials on trial registries within 12 months is increasingly becoming the norm within the UK, a new report released today by the country’s Health Research Authority shows.
The UK is first country worldwide to commit to ensuring that all clinical trials are registered and all their results made public within one year of trial completion, as set out in the national Make it Public strategy.
Find out more here: HOW THE UK SYSTEM WORKS - EXPLAINED IN 153 WORDS
Today’s transparency report of the Health Research Authority (HRA) – an official body that oversees all medical ethics committees in the country – provides a snapshot of the progress made so far.
It covers 709 completed final reports received for health research projects received by the HRA between September 2021 and September 2022. Some, but not all, of these projects were clinical trials.
Progress on trial registration
92% of clinical trials had been registered at the time the HRA received the final reports. This is substantial progress compared to only a few years ago.
However, it also means that at least 8% of clinical trials run in the UK still violate ethics requirements. (The metric does not distinguish between registrations made prior to the start of a trial, as required, and those made in subsequent months.) The report does not mention any HRA sanctions imposed as a result of these ethics violations.
COMMENT: The Make It Public strategy envisioned completely solving the problem by putting the HRA iin charge of directly registering all trials following ethics approval. So far, the HRA is doing this only for a minority of trials. In the report, the HRA does not commit to a date for universal central registration.
Progress on results reporting
Nearly half (44%) of all clinical trials in the cohort had made their results public in a trial registry within 12 months of completion. This is a dramatic and important improvement.
Only a few years ago, UK companies and institutions typically limited their registry reporting efforts to drug trials only. Registry reporting has multiple advantages over other publication formats: reducing the risk of research waste, speeding up medical progress, and providing more complete and accurate data on trial outcomes.
COMMENT: A key weakness of the Make It Public strategy is that while it requires results to be made public within 12 months, it does not require reporting specifically on a trial registry, despite this being a WHO best practice.
However, the report notes that this may change if and when the UK adopts national legislation requiring all trial results to be rapidly made public – hopefully on registries. Also, there is an ongoing WHO-led process to standardise reporting formats across trial registries worldwide, which may influene the HRA's own approach.
It is highly encouraging to see that many UK companies and institutions are already getting ahead of the transparency curve.
Transparency towards patients
The report notes that 83% of clinical trials provided a lay summary of results. In addition, 29% of studies informed participants of results, but as not all ‘studies’ were clinical trials, it is unclear what percentage of trials did so.
Transparency gap 1: Missing results
The report does not tell us how many trials did not report results at all within the 12-month deadline because the reference cohort only includes clinical trials whose results were shared with the HRA. The HRA is promising to fix this in future. According to the report:
“We are building a new system to collect data and monitor final reporting for all types of studies. Until it’s ready, we’ll be reporting the number of final report forms completed, even though this is not a perfect measure.”
Transparency gap 2: Who broke the rules?
The HRA states that its annual transparency report “allows us to celebrate good practice and highlight poor performance”. The report fully delivers on the celebration part – it contains several informative case studies of health research done well.
But... who has been breaking the rules?
The report does not list companies and institutions that failed to register clinical trials as required.
The report does not list sponsors that failed to rapidly make results public as required.
The report does not link to the underlying dataset (which is somewhat ironic)
The HRA is continuing its tradition of shielding those who break the rules from public view.
TranspariMED will file a Freedom of Information request for these data, as it has done in previous years.
Sanctions are essential
To get to the 100% of trials pre-registered and 100% of trials rapidly reported that were demanded by UK parliament and promised to UK patients, we need new legislation that includes actual sanctions.
TranspariMED and allied groups will continue to engage until that aim has been achieved.
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UK research transparency events 20-24 March
From 20 to 24 March 2023, the HRA is hosting a series of talks and workshops on improving transparency in medical research. Please visit the HRA website to find out more.
