Proposed UK trial rules would increase clinical trial transparency
Proposed changes to the rules that govern clinical trials in the UK would require sponsors to register on a public database and share results with participates.
The transparency measures are part of a wider plan to overhaul the oversight of clinical trials in the UK, which was debated in parliament last month.
Under the proposed legislation, sponsors must register their trial in a public registry within 90 days of gaining regulatory approval or when they recruit the first participant, whichever happens sooner.
In addition, after the study completes, the sponsor must “publish a summary of the results of the clinical trial in the same public registry” and offer “all relevant persons a summary of the results written in a manner that is understandable to laypersons.”
Patient safety
Requiring sponsors to share this information will enhance the safety of people who take part in drug trials, according to Baroness Merron, Parliamentary Under-Secretary of State at the Department of Health and Social Care.
“These reforms will ensure patients, and their safety, are at the focus of all clinical trials and - supported by greater transparency – will bring the benefits of clinical trials to everyone.
“When approved by Parliament, this legislation will represent the most significant reform of UK clinical trials regulation in over 20 years,” she said, predicting it would address the “need for a more efficient and adaptable regulatory framework, while safeguarding the wellbeing of trial participants.”
Regulatory clarity
The proposed reforms were welcomed by Matt Westmore, chief executive of the UK government-linked Health Research Authority, who said, “The new regulations signal the UK’s high expectations for how clinical trials should be conducted and set clear requirements for research transparency.
“When the new law comes into force, supporting guidance will ensure that everyone understands what is expected and how to do it.”
The proposed changes are in keeping with recommendations that emerged from a 2023 review of the UK trials landscape by Lord James O’Shaughnessy, founder and senior partner at medical consulting group Newmarket Strategy.
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