AQW 32505/22-27

Mr Stewart Dickson
Alliance Party
East Antrim

Tabled Date: 01/10/2025
Answered On Date: 13/10/2025
Priority Written: Yes

Question:
To ask the Minister of Health, given that the UK-wide BEST4 trial of capsule sponge testing for Barrett’s oesophagus and oesophageal cancer has already been approved in Great Britain and is already recruiting, to detail what immediate action will his Department take to ensure patients can access this UK-wide clinical trial, noting that the Belfast Health and Social Care Trust has had the fully funded NI trial documentation for over a year for approval.

Answer:

The Belfast Health and Social Care Trust is currently unable to participate in the BEST4 trial due to aspects of the trial not being compliant with the European Union In Vitro Diagnostic Regulation (EU IVDR 2017/746). The sponsor of the trial, Cambridge University Hospitals NHS Foundation Trust, will be required to submit an application to the regulator MHRA, to enable the trial to progress.

The Local Information Pack (LIP) application for the BEST 4 study was received by the Belfast Health and Social Care Trust’s Research Office from the study sponsor on 4 October 2024. The Belfast Health and Social Care Trust are still awaiting the release of the Study Wide Governance Report from the PHA HSC Approvals Service, to facilitate their participation, which is dependent on resolution of the EU IVDR compliance issue. Until this report is received, the Belfast Health and Social Care Trust cannot progress to the opening of the trial. I understand that discussions are ongoing between the HSC Approvals Service, the trial sponsor and the MHRA to resolve the regulatory requirements in NI for the trial.

However, I am pleased to share that the Northern Ireland Cancer Network’s Upper Gastrointestinal Clinical Reference Group are reviewing clinical evidence, including guidance from NICE and the British Society of Gastroenterology, alongside research findings, to determine the most clinically appropriate contexts for potential implementation of capsule sponge testing across the region.