Phase 1 Accreditation in a Changing Clinical Research Environment: Bridging the Gap Between Governance and Practice

抄録

The landscape of early-phase clinical trials is undergoing a significant transformation. First-in-human (FIH) trials, once primarily conducted in healthy participants, are increasingly being carried out in patient populations with relevant diseases. A growing number of these trials now take place outside of MHRA-accredited trial locations, many of which are unable to pursue accreditation due to the associated financial burden. These trials often involve complex and high-risk therapies—such as in-vivo gene editing, immunotherapies, and targeted treatments - that require specialist clinical oversight and robust infrastructure. This shift challenges the suitability of traditional Phase 1 accreditation frameworks, which were originally designed around Clinical Pharmacology Units (CPUs). While CPUs may lack the necessary facilities and expertise to safely administer these therapies, hospital-based research units, though better equipped for inpatient care and safety monitoring, often fall short of meeting MHRA FIH governance standards. To safeguard patient safety and uphold public trust in emerging technologies, there is a need to revisit and adapt the Phase 1 accreditation framework. This includes a reassessment of Principal Investigator (PI) qualifications to ensure they reflect the clinical and scientific competencies required for today’s early-phase trials. Building on previous initiatives, this effort aims to align accreditation standards with the realities of modern clinical research. The UK’s Systemic Anti-Cancer Therapy (SACT) framework offers a promising model. It governs the delivery of high-risk therapies in specialist centres under well-defined protocols and is both pragmatic and clinically integrated. Its accessibility to a broader range of clinical environments - closer to patients - makes it a compelling reference point for updating the Phase 1 accreditation. This abstract proposes a strategic review of the Phase 1 accreditation framework to bridge the gap between governance and practice, ensuring that innovative therapies are delivered safely, ethically, and accessibly across a wider network of qualified research sites.