Streamlining Genetically Modified Organism Regulatory Classification in UK Gene Therapy Clinical Trials: A UK...

Accurate classification of Genetically Modified Organism (GMO) gene therapies remains a significant challenge to initiating clinical trials in the United Kingdom, often delaying patient access to innovative treatments. Current regulatory processes require separate GMO risk assessments at each National Health Service (NHS) trial location, leading to inconsistent approaches and duplication of effort. This article presents the development of a decision tree designed to streamline GMO classification for Gene Therapy Investigational Medicinal Products (GTIMPs). The proposed tool aims to address key challenges in trial setup by providing a structured and evidence-based approach to GMO classification, clarifying international misalignment in hazard classification and offering practical guidance for the in vivo and ex vivo GMO GTIMPs most encountered in clinical practice. By harmonizing decision-making and clarifying containment requirements, the adoption of the decision tree across NHS organizations could reduce variability, accelerate trial setup, and strengthen the United Kingdom's position as a competitive destination for GTIMP clinical trials.