Reforms to UK clinical trials framework passed into law

Over the coming 12 months (through 10 April 2026), the Medicines and Healthcare products Regulatory Agency (MHRA), in collaboration with the Health Research Authority, will be working on the implementation of the clinical trial reforms. This process will involve further engagement with industry and will include the development of guidance intended to embed meaningful public involvement in clinical trials and increase the diversity of participants in research trials. 

The key reforms to UK CTR proposed in the December 2024 draft legislation (discussed in more detail in our previous article) have been fully implemented in the final version of the amendment regulations and include: 

• Risk-proportionate Regulation: Regulatory requirements now align with the risk level of clinical trials. Low-risk trials can receive faster approval through automatic authorisation without comprising patient safety. 
• Streamlined Approval Process: A combined review process integrates regulatory and ethics committee approvals, leading to a single UK decision for decision for clinical trials. This aims to reduce duplication and unnecessary delays while maintaining robust oversight of trial safety. 
• Enhanced Transparency Requirements: New legal obligations mandate the registration of clinical trials in public registry and the publication of trial results within 12 months of the trail's conclusion. This initiative aims to build public trust in research by improving access to information about ongoing studies. 

The following key elements have also been confirmed in the final amendment regulations: 

• Notification Scheme for Low-Risk Trials: A notification scheme has been introduced for lower-risk clinical trials, enabling sponsors to notify the MHRA about eligible trials where the risk to participant is similar to standard medical care. This streamlined process facilitates faster initiation of these trials without compromising safety. 
• Extended Archiving Period: The regulations now require the archiving of trial master files for 25 years, an extension from the previous 5-year requirement. This change ensures long-term accessibility to trial data for future reference and analysis. 
• Sunset Period for Trials Approvals: Clinical trial approvals will now lapse after a proposed sunset period of two years if no participants have been enrolled. This measure encourages timely initiation of trials and optimises resources allocation. 

The amendment regulations signify a transformative shift in the UK's approach to clinical trials, emphasizing patient safety, regulatory efficiency and research transparency. 

Authored by Jane Summerfield, Bonella Ramsay, and Bea Watts.