Summary: UK response to clinical trials consultation

United Kingdom

The UK government has published its response to a consultation on legislative proposals for clinical trials, outlining its proposed changes to the regulation of clinical trials in the UK. The response aims to improve transparency and patient focus, reduce administrative burden, maintain safety standards, and align with international frameworks. Ultimately, the goal is to make the UK more competitive as a location for clinical research.

The response proposes new requirements for transparency, such as trial registration, results reporting, and sharing findings with participants, to enhance public trust and accountability. It also streamlines and simplifies the approval process, by combining the MHRA and ethics review, setting competitive timelines, and adopting risk-based approaches. These changes are expected to reduce delays and costs for trial sponsors and investigators, and to facilitate innovation and collaboration.

The response also proposes to “balance” the changes to UK clinical trial regulations against the ICH Good Clinical Practice principles, to ensure consistency across international trials. It provides provisions to support patient diversity and involvement, such as flexible, proportionate consent models, to increase the relevance and acceptability of trials. That said, there will be no mandatory targets regarding diversity. It proposes to update the rules on manufacturing, labelling, and licensing, to improve the supply and distribution of trial medicines.

One of the most notable changes is the introduction of a notification scheme for low-risk trials, such as those involving minimal interventions or existing medicines. This scheme will allow trial sponsors to notify the MHRA of their trial plans, without requiring a full application and approval. This will enable faster and easier access to low-risk trials. Ethics approval will, however, still be required.

The response also explains why some changes were not taken forward, such as requiring non-compliance information in new trial assessments, collecting data on unlicensed medicines, mandating population diversity, and legislating public involvement. The reasons for these decisions include practicality, feasibility, proportionality, and flexibility.

The response concludes by outlining the next steps for drafting and implementing the new legislation, developing guidance with stakeholders, and working on the broader clinical research vision. The response indicates that the government is committed to making the UK a leading destination for clinical trials, and to supporting the life sciences sector. To quote the report: “Our legislation will ensure the UK is a preferred global destination to conduct clinical trials and develop innovative medicines.”