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.

In this episode of the Vital Health Podcast, host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/">Duane Schulthess</a> speaks with two experts on evidence standards for early oncology access at ISPOR Europe 2025 in Glasgow, Scotland:
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<a href="https://www.linkedin.com/in/oriana-ciani-bb029a8/?originalSubdomain=it">Oriana Ciani:</a> Associate Professor of Practice at <a href="https://www.linkedin.com/school/sda-bocconi-school-of-management/">SDA Bocconi School of Management</a>
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<a href="https://www.linkedin.com/in/denislacombe/?originalSubdomain=be">Denis Lacombe:</a> Director General at <a href="https://www.linkedin.com/company/eortc/">EORTC</a>
</li>
</ul>
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:
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<li data-start="9929" data-end="10028">
Accelerated Approvals: Unmet need concepts, regulatory pathways, and access pressure in oncology.
</li>
<li data-start="10029" data-end="10123">
Rare Trial Design: Small populations, randomization feasibility, comparator constraints.
</li>
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Surrogate Endpoints: Progression-free survival, early-stage endpoints, evidence needed to validate surrogates.
</li>
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HTA Variation: Differing national standards, uncertainty handling, reimbursement timing effects.
</li>
<li data-start="10344" data-end="10469">
Treatment Optimization: Post-authorization evidence gaps, dose and duration questions, aligning evidence needs earlier.
</li>
</ul>
Opinions expressed are those of the speakers.&nbsp;This podcast was supported by Merck Sharp &amp; Dohme as part of the APACE project, in collaboration with GlaxoSmithKline and AstraZeneca.

Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast.  Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.

Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast.  Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.

Duane Schulthess, Managing Director of Vital Tran…