S3004
Invited Speaker
ESTRO 2026
importance of randomised evidence, the legitimacy of alternative and prospective observational designs in specific contexts, and the need to broaden the endpoint landscape beyond overall survival.
2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC AI-act: REGULATION (EU) 2024/1689 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) 5327 Health economics framework and value assessment in radiation therapy trials Marianne Aznar Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom Radiotherapy is a cornerstone of cancer management, yet it remains systematically undervalued in health technology assessment and reimbursement frameworks. In this presentation, we will argue that existing value-based appraisal tools — developed primarily for systemic therapies — are fundamentally unsuited to the diversity of radiotherapy innovations, and that the field urgently needs its own framework. We will first examine why appraising radiotherapy is uniquely challenging: the sheer range of intervention types, the scarcity of randomised trial evidence, the slow translation of radiotherapy-specific benefits into traditional endpoints such as overall survival, and the structural underfunding of radiotherapy research. These challenges have real consequences e.g. delaying patient access to high-value innovations while simultaneously enabling the adoption of low-value interventions without adequate evidence of benefit. We will then present the step-by-step development of a radiotherapy-specific value assessment framework, built within the ESTRO Value-Based Radiation Oncology (VBRO) programme. This includes a validated categorisation system (differentiating between Drug-centred, Radiation-centred, Radiation- enabling, and Operational interventions) developed through a rigorous multi-method co-creation process with broad stakeholder representation. We will show how a large-scale bibliometric analysis confirmed that these categories differ meaningfully in their evidence base and endpoint focus, making a category-specific appraisal approach not just desirable but necessary. Finally, we will present the results of an international Delphi consensus study, in which the radiation oncology community reached agreement on the priority study designs and endpoints required to demonstrate meaningful benefit for each category of innovation. Key messages include the continued
5329 How to make a radiotherapy clinical trial successful: Lessons learned in over 2 decades of trial design Emma Hall Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom Radiotherapy trials are often motivated by technological or dosimetric advances, yet only succeed if they address a meaningful clinical question. Drawing on over two decades of experience designing, delivering, and analysing large multicentre radiotherapy trials, this talk reflects on what makes such trials successful — and why others might fall short. A central lesson is the importance of aligning trial design with a clear clinical problem relevant to patients and clinicians, rather than technology alone. Dosimetric or model-based improvements must be linked to plausible biological mechanisms and anticipated clinical benefit, such as improved tumour control, reduced toxicity, or better quality of life. Translating theoretical advantages into clinically meaningful outcomes remains challenging and has implications for endpoint selection, statistical power, and follow-up, particularly where late toxicity is critical. Trials must be designed to give a realistic chance of detecting benefits that are both statistically robust and clinically relevant. The talk will discuss principles of efficient trial design, including appropriate comparators, simplicity, and feasible yet rigorous methodologies. Practical aspects of multicentre trial delivery will also be considered, including treatment standardisation, quality assurance, and multidisciplinary engagement. Examples from practice-changing trials will be used to illustrate pragmatic lessons for future radiotherapy studies. AIA HAb Se Hin R v1.0
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