- How real-world data (RWD) can be used to support clinical trials
- Illustrative example using UK electronic healthcare records
- Key MHRA guidance on RWD for clinical trials
- Regulatory requirements data quality
- Transparency reporting recommendations
Archives: Agenda
PANEL DISCUSSION: Designing Oncology Trials That Work for Every Patient
- Tackling barriers that limit access and participation for under-represented patient groups.
- Ensuring cultural relevance, language accessibility and equitable site selection.
- Embedding PROs and patient insights to shape inclusive eligibility and trial procedures.
- Measuring what matters: evaluating the impact of patient-centred designs on recruitment and retention.
CASE STUDY: Gene Therapy in Action: Advancing a Clinical Case Study in Childhood Dementia
| This session will explore the translational journey of a novel gene therapy targeting childhood dementia, from early research through to clinical trial readiness. Using a real-world case study, it will highlight the scientific, regulatory, and operational challenges involved in bringing a cutting-edge therapy to patients, and what this means for outsourcing partners across the UK & Ireland.
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150 Days to Activation: Can the UK Meet the NIHR’s New Trial Start-Up Standard?
- What the new national target requires from sites and sponsors
- Meeting the NIHR’s new FPI targets: 30days for Rare, 60 days for all others
- Systemic challenges slowing UK clinical trial delivery
- Enablers: streamlined processes, capacity, and perforMaria Koufali mance management
- What success looks like for 2025–2026
Morning refreshments and networking
PATIENT SPOTLIGHT: Improving Preclinical and Clinical Research Through Patient Integration
- Integrating patients into study design brings increased efficiency and focus – it’s about more than improving recruitment
- Practicalities of integrating patients based on real world experience
Morning refreshments and networking
KEYNOTE: A New Chapter for UK Clinical Trials: Regulation Reform and the Rise of AI
- The impact of the new UK clinical trial regulations coming into force in April 2026 and what they mean for sponsors, investigators, and trial delivery
- Government priorities and progress across the UK clinical research ecosystem two years on
- How artificial intelligence is transforming clinical trial design, feasibility, patient identification, and operational efficiency
- Cross-sector collaboration between regulators, industry, and the NHS to strengthen the UK’s position as a leading destination for clinical research
- Looking ahead: building a more agile, technology-enabled clinical trials environment in the UK