Morning, Tuesday, 15th December 2026
Online
This conference will examine priorities for clinical research and trials in the UK. Areas for discussion include next steps for translating regulatory reform into faster and more reliable trial delivery, widening participation as recruitment routes and research models evolve, use of health data and genomics, capacity across the NHS and wider research system, and priorities for advanced therapies and commercial research.
It will bring together policymakers and stakeholders to assess early experience of the UK’s amended Clinical Trials Regulations, including the impact of the move towards more proportionate, risk-based regulation on improving approvals. Delegates will also consider approaches to addressing remaining barriers to faster and more consistent delivery. With concerns continuing around delays after regulatory approval, discussion will examine priorities for improving trial set-up and the consistency and predictability of delivery across different sites and organisations.
The agenda will also consider priorities for widening participation in clinical trials among patients and the wider public, including next steps for national recruitment services, use of health data and decentralised trial models. Attendees will examine where further progress may be needed in access for underserved groups and across different parts of the UK, alongside practical questions arising as recruitment and participation extend beyond traditional trial settings.
Further discussion will focus on strengthening clinical research capacity across primary, secondary and community care, including where constraints continue to affect the ability of sites and systems to take on and deliver research. Delegates will also examine readiness for increasingly complex trials and advanced therapies, and priorities for improving the consistency of commercial trial delivery and maintaining the UK’s attractiveness for research and investment.
Clinical Trials Regulations - approvals, trial set-up & oversight
Sessions will examine the move towards more proportionate, risk-based oversight, including experience of the new regulatory routes in practice, and where further barriers to faster and more consistent trial delivery remain.
Overall, areas for discussion include:
- approval pathways: experience of Combined Review and notifiable trials - implications for sponsors, researchers, trial sites and participants
- trial modifications: the Route B pathway for eligible substantial modifications - experience of the new process and its impact on amendments to ongoing trials
- early-phase research: progress with the MHRA’s Phase 1 pilot - staged reductions towards a 14-day first assessment target for eligible trials by the end of 2026
- coordination:
- site set-up, contracting and responsibilities between sponsors, research organisations and trial sites
- addressing delays between regulatory approval, site set-up and first-patient recruitment
Participation & recruitment
Approaches to widening access to clinical research will also be examined, including the UK-wide NIHR Be Part of Research service and plans to link clinical trial recruitment with the NHS App in England. Delegates will consider where barriers remain to more accessible and representative recruitment, with attention to practical approaches to reaching underserved communities, people who may be missed by existing recruitment routes, building public confidence and patient involvement in research.
Overall, areas for discussion include:
- recruitment pathways: patient awareness of and access to trials - next steps for national and digital recruitment services and their use alongside local and community-based routes
- equitable access: participation among under-represented groups and underserved communities - geographical and socioeconomic inequalities and barriers to participation
- public involvement: patient involvement in trial design - community engagement and culturally appropriate recruitment - clear communication about what participation involves
Health data, genomics & digital research
Discussion will consider next steps for the use of NHS data, the developing Health Data Research Service, genomics, and digital innovation in supporting clinical research. Attendees will assess priorities for improving access to health data and interoperability while maintaining public confidence and appropriate safeguards, alongside the practicalities and accessibility of extending participation beyond traditional hospital settings.
Overall, areas for discussion include:
- health data: development of the Health Data Research Service - data access, interoperability, confidentiality and governance - requirements for researcher access and public confidence
- genomics: access to biomarker testing - implications for personalised medicine, patient identification and precision trials
- decentralised trials:
- remote monitoring and virtual follow-up - consent, oversight and safety monitoring outside traditional trial sites
- accessibility and practical requirements for participants and research teams
- AI applications: responsible use in trial design, recruitment, monitoring and delivery - validation and accountability, and implications for research teams and participants
Research capacity, workforce & local delivery
Further sessions will consider where research infrastructure and workforce constraints are affecting the ability of sites to take on and deliver studies across different care settings. Delegates will assess priorities for strengthening capability across primary, secondary and community care, and for translating improvements in national infrastructure into faster and more reliable local delivery.
Overall, areas for discussion include:
- research capacity: infrastructure and support for trial delivery across care settings - variation in capacity and capability between research organisations and local sites
- workforce development: recruitment, retention and access to specialist research skills - capability across trial set-up, recruitment and delivery teams
- staff support:
- protected time and practical support for clinicians and other NHS staff undertaking research alongside clinical responsibilities
- pressures on capacity for research alongside service delivery
Advanced therapies & commercial research
Attendees will also discuss what may be needed to support research into cell and gene therapies, regenerative medicine and personalised cancer vaccines, and priorities for strengthening the UK’s ability to attract and reliably deliver commercial trials. Discussion will consider readiness across regulation, infrastructure, specialist capability, NHS sites and recruitment pathways to support increasingly complex studies and emerging therapies.
Overall, areas for discussion include:
- advanced therapies: implications for trial pathways and delivery models - infrastructure, workforce and site capacity to support research into emerging treatments
- cancer & vaccines: the planned Cancer Clinical Trials Accelerator Programme, Vaccine Innovation Pathway and Cancer Vaccine Launch Pad - screening, recruitment and delivery considerations
- collaboration: partnerships between the NHS, academia and industry - allocation and coordination of expertise, infrastructure and research delivery
- commercial research:
- maintaining the UK’s attractiveness and competitiveness for clinical trials
- reliability and predictability of delivery and implications for investment and commercial partnerships
Safety, transparency & ethical oversight
Across the agenda, delegates will examine the practical application of participant protection, safety, transparency and ethical requirements under the amended regulatory framework. This includes where proportionate regulation and new research models raise issues for sponsors, researchers, ethics committees and participants, alongside the responsible use of AI and digital technologies in clinical research.
Overall, areas for discussion include:
- safety reporting: proportionate pharmacovigilance and reporting requirements - participant protection and regulatory confidence - practical experience of new requirements
- ethical oversight: considerations for lower-risk and decentralised trials - consent and proportionate review - responsibilities where research takes place outside conventional trial sites
- research transparency:
- implementation of statutory requirements for trial registration
- publication of summary results within 12 months of trial completion, subject to applicable exceptions - sharing findings with participants
All delegates will be able to contribute to the output of the conference, which will be shared with parliamentary, ministerial, departmental and regulatory offices, and more widely. This includes the full proceedings and additional articles submitted by delegates.
