Legislative milestone for UK clinical trials

New legislation is set to facilitate a “more efficient, streamlined and adaptable regulatory framework” for UK clinical trials, according to the Medicines and Healthcare products Regulatory Agency (MHRA). This marks a major milestone in the agency’s biggest overhaul of the clinical trial regulations in two decades, MHRA affirmed.

Updating the framework will help enhance the UK as an attractive destination for “conducting groundbreaking, safe clinical trials”, aligning with recommendations from the Lord O’Shaughnessy Review, the agency added.

Amendments made to the legislation include:

• Ensure that protection of clinical trial participants is central in the legislation
• Facilitate evaluation and development of new or improved medicines
• Eliminate hurdles in achieving innovation, while maintaining robust oversight of the safety of trials
• Ensure the legislation enables sponsors of clinical trial to work across countries, ensuring the UK is a preferred site for conducting multi-national clinical trials.

“Passing this much-anticipated legislation is an essential step toward providing the certainty commercial trial sponsors need to invest in and plan more clinical trials in the UK,” explained Dr Janet Valentine, Executive Director of Innovation and Research Policy at the Association of the British Pharmaceutical Industry (ABPI).

Optimising delivery of UK clinical trials

“A major milestone for clinical trials regulations has been achieved today… we’re introducing regulations that eliminate unnecessary duplication and accelerate approvals. These reforms protect the safe development of pioneering new treatments for the benefit of patients and the NHS, setting the UK as one of the best places in the world to conduct research for patients, researchers and innovators,” Dr June Raine, MHRA Chief Executive commented.

“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,” Dr Matt Westmore, HRA Chief Executive stated.

“The announcement is timely. In September, the World Health Organization [WHO] issued new Best Practices for Clinical Trials which set out the key principles that all clinical trials should meet. I trust that the new legislation will enable the UK to deliver clinical trials of the highest quality effectively and efficiently, mindful of the needs of clinicians, patients and the public,” Professor Sir Martin Landray,  Professor of Medicine & Epidemiology, Nuffield Department of Population Health, University of Oxford, Co-lead, RECOVERY trial of treatments for COVID-19, Chief Executive, Protas, shared.

The new legislation will be enforced following a 12-month implementation period.

In line with this development, in October 2023, the MHRA announced its notification scheme for the lowest risk trials. A case study was published in May this year.