Morning, Tuesday, 15th December 2026
Online
This conference will examine next steps for clinical research and trials in the UK, in the context of the implementation of the UK’s amended Clinical Trials Regulations which took full effect in April 2026. Areas for discussion include regulatory implementation, trial set-up and approvals, patient recruitment and participation, data and digital research models, and innovation in advanced therapies.
Implementing amended Clinical Trials Regulations - approvals, oversight & coordination
It will bring together policymakers and stakeholders to assess progress of the new regulatory framework, including its impact on approval timelines, trial set-up and delivery, and the practical experience of sponsors, researchers and trial sites.
The discussion takes place in the context of the Combined Review, notifiable trials, the Route B pathway for substantial modifications, and the move towards more proportionate, risk-based oversight, alongside initiatives such as the MHRA’s Phase 1 pilot - which is reducing first assessment times in stages towards 14 days for eligible trials by the end of 2026. Delegates will consider what these developments mean for coordination between the MHRA, HRA, the NHS, industry, researchers and trial sites, and where further barriers to faster and more consistent trial delivery remain.
Widening participation, the role of data, genomics & digital models
Approaches to widening access to clinical research will also be examined, including the use of the NHS App in England alongside the UK-wide NIHR Be Part of Research service. Delegates will also look at recruitment pathways for under-represented groups and underserved communities, and approaches to clear communication and building public confidence and patient involvement in research. Discussion is expected on the role of NHS data, the emerging Health Data Research Service, genomics, and digital innovation in supporting clinical research, including questions around interoperability, confidentiality and biomarker testing. Attendees will also consider decentralised trial models, with attention to consent, safety monitoring and participation beyond traditional hospital settings.
Research infrastructure & system capacity
Further sessions will consider the research infrastructure, workforce capability and delivery capacity needed across primary, secondary and community care. Delegates will assess how research can be embedded more consistently across the NHS and wider care system, including the capacity and skills required for trial set-up, recruitment and delivery, and how improvements in national infrastructure can translate into faster and more reliable local delivery.
Innovation, advanced therapies, commercial research & AI
Attendees will also discuss innovation, advanced therapies, and commercial research, including what may be needed to support research into cell and gene therapies, regenerative medicine and personalised cancer vaccines, and how the UK competes for commercial trial placement. The role of initiatives such as the Cancer Trials Accelerator Programme and Cancer Vaccine Launch Pad will also be assessed, alongside wider questions around safety, transparency, ethics, data governance, and the responsible use of AI in clinical research.
Overall areas for discussion
- clinical trials regulation & delivery:
- implementation and early experience of the UK’s new Clinical Trials Regulations - progress on faster approvals, notifiable trials, and proportionate, risk-based oversight
- Combined Review and approval pathways - implications for sponsors, researchers, trial sites and participants
- coordination between the MHRA, HRA, NHS, industry and research organisations - supporting effective trial set-up and delivery
- assessing new approaches to accelerating early-phase research, including the 14-day Phase 1 assessment pilot
- Route B and the assessment of substantial modifications - experience of the new pathway and its impact on trial amendments in progress
- patient access, recruitment & participation:
- expanding participation through the NHS App in England and the UK-wide NIHR Be Part of Research service - improving patient awareness of and access to clinical trials
- recruitment pathways for under-represented groups - addressing geographical and socioeconomic inequalities in access
- public trust and community engagement - patient involvement in trial design, culturally appropriate recruitment strategies, and communicating what participation involves
- data, genomics & digital innovation:
- NHS health data and the Health Data Research Service - data access, interoperability, confidentiality and public confidence
- genomics and biomarker testing - supporting personalised medicine and precision trials
- digitally enabled and decentralised trial models - remote monitoring, community-based recruitment, virtual follow-up, consent, oversight and safety monitoring
- research infrastructure, workforce & system capacity:
- sustainable clinical research capacity across primary, secondary and community care - supporting delivery beyond traditional hospital sites
- workforce capability in clinical research delivery - skills, capacity and support for teams involved in trial set-up, recruitment and delivery
- embedding research across the NHS and wider care system - practical considerations for consistency, coordination and local delivery
- innovation, advanced therapies & commercial research:
- access to innovative medicines, advanced therapies, and personalised cancer vaccines - implications for trial pathways and delivery models
- Cancer Trials Accelerator programme, UK Vaccine Innovation Pathway and Cancer Vaccine Launch Pad - screening, recruitment and delivery considerations
- international competitiveness and inward investment - trial incentives, infrastructure, and commercial partnerships
- safety, transparency & ethics:
- proportionate safety reporting and pharmacovigilance under the new regulatory framework - participant protection and regulatory confidence
- ethical considerations for lower-risk and decentralised trials - proportionate oversight of notifiable trials, data governance, and responsible use of AI and digital technologies in research
- statutory transparency requirements - trial registration, publication of results within 12 months, and offering findings to participants
