CDDF Multi-Stakeholder Workshop
Enabling Smarter Clinical Trials
17 November – 18 November 2025, Hybrid Workshop
Presentations
SESSION 1: Clinical trials and real world evidence: what really matters
Enabling Clinical Trials: Taking a proportionate approach – focusing on what really matters – Juan Estevez (AEMPS, ES)
Turning Data into Decisions: Real-World Evidence in Regulation – Alexandra Pacurariu (EMA, NL)
SESSION 2: Use of pragmatic elements in clinical trials
Matching trials aims to design decisions: how PRECIS-2 can help, and how PRECIS-3 will be better – Shaun Treweek (University of Aberdeen, UK)
Patient perspective – Gilliosa Spurrier-Bernard (MelanomeFrance, FR)
Designing trials with pragmatic elements to generate high-quality real-world evidence for regulatory decisions – Nafsika Kronidou-Horst (Roche, CH)
Safety data report – ICH E19 – how we streamline – example of pragmatic elements – regulatory component – Peter Mol (University of Groningen, NL)
SESSION 3: Driving research using health data
EMA article – clinical evidence 2030 – Marianne Lunzer (CTCG, AT)
Unlocking the Power of Real-World Data Across the Full Lifecycle of Cancer Clinical Trials – Ariel Bourla (Johnson & Johnson, U.S)
From Patient Experience to HTA Evidence: The MyLymphoma Model for Real-World Data Generation – Natacha Bolanos (Lymphoma Coalition, ES)
Supporting drug development through new evidence generation approaches – Alison Cave (Medicines and Healthcare products Regulatory Agency, U.K)
Round table discussion “How will the EU health data space empower cancer clinical trials in EU” – Alexandra Pacurariu (EMA, NL)