New Bill could enhance UK clinical trial regulation

A report published by the Policy Exchange has highlighted how The Future Clinical Trials Bill could improve the UK’s approach to the establishment and regulation of clinical trials.

The new Bill is part of a range of proposed policies for implementation under the new legislative programme that will be set out in the final session of this Parliament.

Benefits of The Future Clinical Trials Bill

Chiefly, the Bill’s goal is to increase patient participation and overall, ensure clinical trials have the highest levels of safety while enabling greater regulatory pragmatism, the author explained. If achieved, this would boost the UK’s competitiveness as a leading international site for trials.

The report’s author, Iain Mansfield, Director of Research and Head of Education and Science at Policy Exchange, stated that The Future Clinical Trials Bill is essential as there are currently challenges restricting the activity of clinical trials in the UK. As such, certain actions are required to successfully deliver these trials. These actions include faster and more flexible clinical trial set-up, design & regulation.

The UK’s approach has been regarded as “consistently slow”, Mansfield wrote. He highlighted research by the Association of the British Pharmaceutical Industry (ABPI) from 2022, which found that between 2018 and 2020, “the median time between application for regulatory approval and delivery of a first dose to a participant in a trial increased by almost a month.”

Comparatively, Mansfield shared that Spain has witnessed significant improvements in recent years with the introduction of legislation which mandates strict timelines for approval. “Timeframes to set up trials were reduced (on average) by 15 percent within a year of the legislation coming into force.” This is according to a 2016 paper published in Clinical and Translational Oncology.

Mansfield also listed the main elements of The Future Clinical Trials Bill. A selection are shown below:

• The Legislation would update The Medicines for Human Use (Clinical Trials) Regulations 2004, which is based upon the EU Clinical Trials Directive
• Provisions to guarantee greater transparency: set-up, participation and result sharing
• A requirement to register trials via the Health Research Authority (HRA), who then register trials with the ISRCTN Registry, which is the primary, internationally-recognised clinical trial registry acknowledged by the World Health Organization (WHO).
• A requirement to publish a summary of results within twelve months once a trial has completed, to encourage future participation. This is unless a deferral has been agreed.
• Introduction of a duty for the National Institute for Health and Care Research (NIHR) to collect and publish national monthly returns on NHS clinical trials activity across. This activity should bring together relevant data sets which are collected by both the Medicines and Healthcare products Regulatory Agency (MHRA) and HRA.

Regulatory pragmatism for clinical trials

Mansfield noted that the The Future Clinical Trials Bill will include the introduction of a standard combined MHRA and Research Ethics Committee (REC) review of applications within thirty days after validation, significantly shortening timelines set out in law, compared to current EU regulation.

A new sixty-day limit would be implemented for those conducting a trial to respond to Requests for Further Information (RFI) from the MHRA or Research Ethics Committees (RECs). This would provide sufficient time for sponsors to prepare responses to satisfy regulators, according to the report.

In the report it was acknowledged that the Bill would introduce a notification scheme for low intervention trials, as well as removing the requirement for individual ‘Suspected Unexpected Serious Adverse Reactions’ (SUSARs) to be reported to all trial investigators.

The Future Clinical Trials Bill provisions will “mandate transparent trial registration and facilitate swifter approval” Mansfield summarised.