Study Set-Up Plan update: Progress and next steps

Phase 2 of the UK Clinical Research Delivery Study Set-Up Plan is complete, but there is more to do. This webinar offers reflections from UK research system partners who are instrumental in its delivery. It also provided an update on the Plan and next steps towards achieving the Government's target of reducing clinical trial set-up time to 150 days. Speakers: Saeeda Bashir, Head of Clinical Trials Policy & Programmes, DHSC Lindsey Hughes, Director of Research, NHS England Janet Messer, Director of Approvals Service, HRA Kate Jones, Director of Research Delivery, NIHR Research Delivery Network Kingyin Lee, Head of Clinical Trials, MHRA Charles Weller, General Manager, NHS Research Scotland (NRS) Key points - The UK Clinical Research Delivery Programme (UKCRD) aims to streamline study setup across all four UK nations. - The goal is to reduce study setup times to 150 days or less by March 2026, focusing on commercial interventional -clinical trials. - New policies include mandated use of standard agreements and revised commercial chief investigator agreements. - Digital reformation and AI are being introduced to improve efficiency in clinical trial application processes. - The NIHR Industry Hub will provide a joined-up offer for sponsors and targeted support for sites. - Continuous engagement and feedback are crucial for ongoing improvements. - Site-level performance will be monitored against the 150-day target, and the new NIHR RDN funding model will include a performance-based element. - Workstream focus areas include contracting & costing, central reviews, performance tracking, and non-commercial studies. - Key initiatives involve updating the NHS England Directive and investing in Commercial Research Delivery Centres (CRDCs). - Collaboration among sponsors, regulators, and sites is essential for accelerating study setup. - Future focus includes maintaining international competitiveness and ensuring compatible processes across the UK.