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Accelerating cancer treatment optimisation: A multistakeholder roadmap from the Cancer Medicines Forum
Denis Lacombe1, Fábio Cardoso Borges2, Ana E Amariutei3
1European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.
Abstract:
Medicines are often tested in highly controlled environments during clinical trials aimed at rapid development and thorough assessment of their benefits and risks, with key efficacy and safety aspects evaluated for regulatory approval. However, important questions regarding the optimisation of medicines' use in clinical practice may remain unanswered at the time of marketing authorisation, notably those related to the optimal dose, duration, schedule, sequence, and combination of treatments. This knowledge gap is particularly critical in oncology, where patient quality of life must be prioritised, and there is the pressing need to understand the most efficient use of costly innovative therapies in the context of rising cancer incidence and prevalence. Addressing these challenges requires multi-stakeholder collaboration. Organisations within the Cancer Medicines Forum (CMF), co-chaired by the European Organisation for Research and Treatment of Cancer and the European Medicines Agency, have advocated for policy actions promoting treatment optimisation research within the European Union. To advance this objective, the CMF convened a multidisciplinary stakeholder workshop, offering a platform for collaborative dialogue by bringing together experts from governmental bodies, regulatory agencies, health technology assessment bodies, patient organisations, academia, learned societies, industry, public health organisations, clinicians, and investigators. This workshop aimed to examine existing barriers and explore strategies to integrate treatment optimisation into the current cancer clinical research framework, ultimately providing key recommendations, summarised in this review, to systematically embed treatment optimisation in oncology research.
Insights
Optimizing cancer drug use is crucial for patient quality of life and efficient healthcare. The Cancer Medicines Forum (CMF) convened experts to identify barriers and strategies for integrating treatment optimization research into oncology clinical trials.
Area of Science:
- Oncology
- Clinical Pharmacology
- Health Services Research
Background:
- Clinical trials assess drug efficacy and safety for regulatory approval but often leave questions about real-world optimal use unanswered.
- This knowledge gap is critical in oncology, impacting patient quality of life and the efficient use of expensive cancer therapies.
- Rising cancer incidence and prevalence necessitate better understanding of optimal dosing, duration, scheduling, sequencing, and combination treatments.
Purpose of the Study:
- To examine barriers and explore strategies for integrating treatment optimization research into the cancer clinical research framework.
- To foster multi-stakeholder collaboration for advancing treatment optimization in oncology.
- To provide recommendations for systematically embedding treatment optimization in oncology research.
Main Methods:
- Convened a multidisciplinary stakeholder workshop with representatives from governmental bodies, regulatory agencies, health technology assessment bodies, patient organizations, academia, industry, and clinicians.
- Facilitated collaborative dialogue to identify challenges and solutions for treatment optimization research.
- Synthesized discussions and recommendations from the workshop.
Main Results:
- Identified key barriers hindering treatment optimization research in oncology.
- Explored strategies for integrating optimization studies into the existing clinical research framework.
- Developed recommendations for policy actions and research practices.
Conclusions:
- Multi-stakeholder collaboration is essential to address the need for treatment optimization research in oncology.
- Systematic integration of treatment optimization into cancer clinical research is required to improve patient outcomes and healthcare efficiency.
- Policy and research frameworks must be adapted to support ongoing optimization of cancer medicines.
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