Trials Without Borders: New UK Clinical Trial Regulations

The UK is undergoing its most significant overhaul of clinical trials regulations in decades, and U.S. sponsors need to take notice. In this episode of Trials Without Borders, brought to you by Clinical Leader and FlexPoint Bio, host Elena Sinclair and co-host Ross Jackson sit down with UK-based experts to unpack what's changing and where American biotechs most often stumble.

The panel explores the new regulations taking effect April 28, 2026, including 14-day fast-track approvals, the Combined Review process, key differences between the UK CTA and US IND, NHS site contracting, ICH E6(R3) implementation, cell and gene therapy pathways, and the post-Brexit regulatory landscape.

Panelists include Jo Burmester, GCP training consultant; Charlotte Chadwick, early-phase clinical research leader; and Sarah Hutchins, Director of Clinical Operations at U-Ploid Biotechnologies.