UK clinical trials update targets flexibility and responsiveness

The UK is currently updating and reforming its clinical trials regulations, following an extensive review and consultation process.

Medicines regulator, the MHRA, is working alongside the NHS Health Research Authority to future-proof and streamline the clinical trials framework, with draft legislation now before Parliament. The changes will offer enhanced efficiency, accessibility and innovation to improve the attractiveness of the UK as a location for clinical research. This is against a background of improving but still relatively weakened performance of the UK as a location for clinical research (ABPI report - The road to recovery for UK industry clinical trials).

Taking account of feedback from an extensive public consultation process, the main areas of reform are summarised below.

Streamlined approvals through Combined Review 

The Combined Review process, which has been operation for some time, will now be put on a statutory footing. Under this process, a sponsor makes a single application through an electronic portal which goes to both the MHRA and a Research Ethics Committee (REC) at the same time. The aim here is to streamline the process, and complete the review within 60 days. This target for Combined Review is currently being achieved.

Transparency

Clinical trial sponsors will need to:

• register clinical trials in a World Health Organization (WHO) recognised public register
• publish a summary of results within 12 months of the end of the trial
  
• offer to share trial findings with participants promptly, and in accessible language

 Simplified consent procedures

For 'lower risk' trials, a simplified approach to seeking and recording consent will be available. These are trials involving medicines with an existing marketing authorisation, for example, to compare the side effect profiles of different treatments. Rather than a formal consent process, the patient’s clinician will be able to explain the proposed trial to the patient and record their agreement to participate in their medical notes.

Research Ethics Committees

Feedback on the existing requirements for the make-up and operation of Research Ethics Committees indicated that users consider them to be overly restrictive. The new regulations remove the prescriptive requirements, replacing them with a new rule on how an ethics committee should be constituted, aligning with international good clinical practice standards ICH-GCP E6. The objective is to allow RECs increased flexibility to meet demand and respond to particular situations, while remaining aligned to international standards.

Extended archiving period

The archiving period for trial master files will be extended from five to at least 25 years.

Areas to be addressed through guidance

Some of the areas considered for reform will not be set out in legislation, but instead addressed through guidance. These include:

• inclusion and diversity, to ensure that a diverse mix of participants is included in clinical research
• involving members of the public in the design, conduct and dissemination of research.
  

Response to the proposed legislation has been positive. The Cell and Gene Therapy Catapult has called it “the most significant reform of UK clinical trials regulation in over 20 years, addressing the sector's need for a more efficient and adaptable regulatory framework”.

The changes will come into effect 12 months after the parliamentary process is complete. We expect to see accompanying guidance published during the course of 2025.

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