CDDF Multi-Stakeholder workshop
Innovative oncology trial designs
18 – 19 September 2023, Hybrid workshop
Presentations
SESSION 1: Endpoints for innovative clinical trials
Endpoints for clinical trials in oncology – Elisabeth de Vries (UMC Groningen, NL) – did not consent
Regulatory perspective (EU) – Aarón Sosa Mejía (DKMA, DK)
Regulatory perspective (US) – Nicole Gormley (FDA, US) – awaiting speaker consent
HTA perspective – Anja Schiel ( Nowrwegian Medicines Agency, NO)
SESSION 2: Innovative trial designs and estimands
SESSION 3: Towards patient-centric evidence generation
A patient perspective on evidence generation – Ana Amariutei (European Patient Advocacy Institute; WECAN, DE) – did not consent
Synthetic and external control arm – Laurence Collette (GSK, BE)
Project Pragmatica – Donna Rivera (FDA, US) – awaiting consent
SESSION 4: Practicalities on innovative clinical trials
Combinations – Alessandro Crotta (BMS, CH)
Studies on rare populations – Paolo Casali (EURACAN, IT)
Master protocol practicalities (industry perspective) – Brian Simmons (Roche, US) – did not consent
ICH guidance – Fergus Sweeney (Retire clinical trial expert, IE)