Abstract 

In April 2026, the Amendment to the Medicines for Human Use (Clinical Trials) Regulations 2025 will come into effect. Among the new requirements, sponsors must provide trial participants with a plain language summary of results (PLSR).

Syneos Health conducted a regulatory impact assessment to evaluate how these changes affect already established processes for PLSRs and their delivery to participants. The UK Health Research Authority (HRA) requires sponsors to register trials on ISRCTN or ClinicalTrials.gov, noting that the EU Clinical Trials Information System (CTIS) does not meet UK registration requirements. To support compliance, the HRA provides a webpage where sponsors can submit study results in a database format. This includes a dedicated field for the PLSR, allowing text entry and URLs, but does not permit the upload of files or graphics.

While this represents progress toward transparency, a web database poses limitations to clarity, dissemination and engagement. Plain language documents are most effective when supported by graphics, tables and design features that aid comprehension, and are most accessible when provided printed or electronically. Without these, the participant experience may be compromised and their results never seen. Sponsors must explore alternative strategies to disseminate visually accessible summaries alongside compliance with regulations.

This article explores the regulatory, operational and practical implications of the 2026 amendments for the preparation and dissemination of PLSRs. It provides pragmatic guidance for sponsors to prioritise participant-focused communication while staying compliant.