As oncology continues to evolve rapidly – with therapies moving earlier in the disease course and survival improving – endpoints are no longer merely technical measures. They increasingly shape regulatory decisions, reimbursement pathways, clinical practice and long-term sustainability of the health system. In Belgium, this challenge is particularly visible in early access mechanisms such as EEFA, where assumptions about benefit and uncertainty rely heavily on how endpoints are defined and interpreted.
Building on literature review, expert input and multi-stakeholder dialogue, the white paper proposes a structured framework for interpreting clinically meaningful benefit in curative solid tumours. Rather than advocating a single endpoint or rigid threshold, it highlights the need for context-sensitive interpretation that takes into account magnitude and durability of benefit, toxicity and long-term side effects, patient-reported outcomes, and real-world applicability.
A key message of the paper is that the current challenge is not a lack of endpoints, but fragmentation and the absence of a shared language across stakeholders. Regulators, payers, clinicians, patients and industry often operate with different expectations, creating friction and uncertainty. The white paper therefore calls for continuous, structured dialogue and shared responsibility in defining and applying endpoints that are ethically sound, clinically relevant and sustainable.
This publication reflects All.Can Belgium’s core mission as a multi-stakeholder platform: to move from measuring what is measurable to measuring what is meaningful, and to ensure that innovation in cancer care delivers real value for patients within available resources.
The white paper is intended as a starting point for further discussion and collaboration in Belgium, and as an invitation to all stakeholders to engage in shaping a more aligned and patient-centred approach to endpoints in curative oncology.
Read the full white paper here
