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Clinical trials of interventional oncology-moving from efficacy to outcomes
James M Franklin1, Val Gebski2, Graeme J Poston3
1CRUK-MRC Oxford Institute for Radiation Oncology, Department of Oncology, University of Oxford, Oxford OX3 7DQ, UK.
Abstract:
Interventional oncology is a rapidly growing sub-speciality that aims to develop new disease-modifying treatment options beyond conventional surgical and oncological therapies in several disease settings. The evidence for interventional oncology success is dominated by single-arm studies reporting technical success or clinical efficacy. These studies have successfully resulted in the development of new techniques, but are not sufficient to change clinical practice uniformly across health-care systems. This Review discusses why clinical investigators must incorporate measures of cost-effectiveness and patient-reported outcomes into large-scale studies currently being designed to provide robust evidence for changing clinical practice. In particular, interventional oncology trials could be designed to show that certain treatments may be as effective as the current standard of care, but with significantly less morbidity and with better outcomes for patients with cancer. Innovative trial design and awareness of the challenges from interventional studies in other fields of medicine and surgery are also discussed to demonstrate how this new speciality can make progress. Registry-based models are emerging as an alternative means of deriving cohort data and can be used in parallel with local or national commissioning of new services.
Insights
Interventional oncology needs large-scale studies measuring cost-effectiveness and patient outcomes to change clinical practice. Incorporating these measures will demonstrate value and improve cancer care.
Area of Science:
- Oncology
- Interventional Radiology
- Clinical Trials
Background:
- Interventional oncology is a rapidly advancing field developing novel treatments for various cancers.
- Current evidence relies heavily on single-arm studies, limiting widespread clinical practice adoption.
- There's a need for more robust data to support the integration of interventional oncology into standard care.
Purpose of the Study:
- To review the necessity of incorporating cost-effectiveness and patient-reported outcomes into interventional oncology trials.
- To highlight strategies for designing large-scale studies that provide robust evidence for clinical practice change.
- To discuss innovative trial designs and lessons learned from other medical fields.
Main Methods:
- Review of current evidence and trial designs in interventional oncology.
- Discussion of challenges and opportunities for future research.
- Exploration of registry-based models for data collection.
Main Results:
- Single-arm studies, while useful for technique development, are insufficient for uniform clinical practice change.
- Integrating cost-effectiveness and patient-reported outcomes is crucial for demonstrating the value of interventional oncology.
- Innovative trial designs and registry-based models can provide robust evidence.
Conclusions:
- Future interventional oncology trials must include cost-effectiveness and patient-reported outcomes to drive clinical practice change.
- Well-designed, large-scale studies are essential for establishing interventional oncology as a standard of care.
- Registry-based models offer a promising avenue for generating real-world evidence.
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