In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts on evidence standards for early oncology access at ISPOR Europe 2025 in Glasgow, Scotland:

• Oriana Ciani: Associate Professor of Practice at SDA Bocconi School of Management

• Denis Lacombe: Director General at EORTC

They discuss why accelerated pathways are used in oncology, what becomes feasible and risky when patient populations are small, how surrogate endpoints such as progression-free survival can differ from overall survival and quality of life, and why post-authorization evidence generation and treatment optimization shape whether early access translates into sustained patient benefit.

Key Topics:

• Accelerated Approvals: Unmet need concepts, regulatory pathways, and access pressure in oncology.

• Rare Trial Design: Small populations, randomization feasibility, comparator constraints.

• Surrogate Endpoints: Progression-free survival, early-stage endpoints, evidence needed to validate surrogates.

• HTA Variation: Differing national standards, uncertainty handling, reimbursement timing effects.

• Treatment Optimization: Post-authorization evidence gaps, dose and duration questions, aligning evidence needs earlier.

Opinions expressed are those of the speakers. This podcast was supported by Merck Sharp & Dohme as part of the APACE project, in collaboration with GlaxoSmithKline and AstraZeneca.