UK regulatory overhaul aims to make publication of clinical trial results a legal requirement
The UK’s medicines regulator is planning to make the registration of clinical trial results and publication of their results a legal requirement as part of a wider overhaul of UK clinical trial regulation.
Regulator MHRA proposes to enshrine three transparency requirements in law:
Trials must be registered
Trial results must be made public within 12 months of trial end
Trial participants must be informed of trial results
GLOBAL LEADERSHIP IN TRIAL TRANSPARENCY
If adopted, these new legal requirements will set a new global benchmark for excellence in clinical trial regulation:
The MHRA’s proposal covers all interventional clinical trials. In contrast, comparable legal requirements in the European Union and in the United States only cover a minority of trials.
The new rules will probably be effectively enforced. The UK is already building a system to monitor trial registration and reporting, so offenders will be easy to detect. As the MHRA itself is proposing the new laws, it is presumably willing to enforce them.
The WHO recommends that “Legislation or supporting regulations [should include] sanctions if a clinical trial is not registered and/or results are not reported.”
CALL TO ACTION
TranspariMED strongly encourages readers who care about trial transparency to respond to the consultation.
This will take only 5 minutes and involves three steps:
Step 1: Visit the consultation page and enter your details
Step 2: On the next page, click on “jump to next section”
Step 3: On the next page, click on “continue with this section” (Research Transparency)
You can simply click "yes" to support each of the proposed measures, or take some more time to explain your position.
STREAMLINING UK CLINICAL TRIAL REGULATION
The transparency measures are part of a broader overhaul of clinical trial regulation in the UK that aims to “streamline the regulation of clinical trials and reduce unnecessary burden to those running trials” and “support more innovative, high-quality and efficient clinical trials across the UK.”
Among other things, the proposed overhaul would make it easier to run low-risk cluster trials of licensed treatments in the UK. It seeks to take advantage of the UK’s ability to unilaterally regulate clinical trials post Brexit.
However, the UK system will remain broadly aligned with European and global regulatory rules so that it will be easy to include UK study sites into multi-country trials.
THE END OF IMPUNITY IS NIGH
Till Bruckner, founder of TranspariMED, said:
“TranspariMED strongly welcomes the proposal to make clinical trial registration and reporting a legal requirement. UK patients have been demanding this for many years. It is good that their voices have been heard. After decades of impunity, we can finally see light at the end of the tunnel.”
“TranspariMED urges patients, doctors and medical researchers to take five minutes to respond to this consultation and encourage the MHRA to put the proposed transparency measures into place. This is a unique chance to finally fix this problem once and for all.”
A 2021 submission of evidence to UK parliament by Cochrane, Transparency International and TranspariMED summarises current clinical trial transparency laws, law enforcement and compliance challenges in the United States, European Union and the UK.
More background on the MHRA consultation here. The consultation will close on 14 March 2022.