Clinical trials for medicines: ending a clinical trial

AI Summary

Effective April 28, 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance under the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended in 2025. This document applies to all clinical trial sponsors and investigators, detailing their obligations to maintain regulatory compliance throughout the trial lifecycle. The guidance highlights critical issues such as the failure to notify authorities of trial conclusions and the non-publication of clinical results. To address these violations, sponsors must provide written notice of a trial’s global end within 90 days for protocol-compliant conclusions and within 15 days for early terminations. Furthermore, sponsors are required to publish a summary of results in a public registry and offer an accessible version to participants within 12 months of trial completion. For certain paediatric trials, this timeline is shortened to six months. Non-compliance with these publication rules can lead the MHRA to reject future trial applications from the same sponsor. Additionally, trial approvals will automatically lapse if no participants are recruited within two years. To prevent this, sponsors must report the date the first participant is recruited and, if necessary, apply for extensions of up to 36 months by providing justification to the licensing authority.