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  • Review Article
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Clinical trials of interventional oncology—moving from efficacy to outcomes

Nature Reviews Clinical Oncology volume 12, pages 93–104 (2015)Cite this article

Subjects

Key Points

  • Clinical trials in interventional oncology have been successful in demonstrating clinical efficacy, but limited data are available on patient-reported outcomes and cost-effectiveness

  • Investigators have met several barriers in conducting phase III trials in interventional oncology, particularly relating to timely recruitment

  • Important methodological challenges should be considered when planning trials in interventional oncology, particularly those related to selection of trial end points

  • Multicentre trials require careful quality assurance to ensure interventions are consistent across participating centres

  • Innovative and pragmatic approaches to generating robust clinical effectiveness data are being implemented in contemporary trial designs, including the use of registries in evaluating a treatment during commissioning

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.

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Acknowledgements

R.A.S. is supported by the NIHR Biomedical Research Centre Oxford, the Bobby Moore Fund of Cancer Research UK and the UK Medical Research Council.

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Authors and Affiliations

  1. Department of Oncology, CRUK-MRC Oxford Institute for Radiation Oncology, University of Oxford, Oxford, OX3 7DQ, UK

    James M. Franklin & Ricky A. Sharma

  2. Biostatistics and Research Methodology, NHMRC Clinical Trials Centre, University of Sydney, 92–94 Parramatta Road, Camperdown, 2050, NSW, Australia

    Val Gebski

  3. Northwestern Hepatobiliary Unit, Aintree University Hospital, University of Liverpool, Longmoor Lane, Liverpool, L9 7AL, Merseyside, UK

    Graeme J. Poston

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All authors researched the data for the article, provided substantial contributions to discussions of its content, wrote the article and undertook review and/or editing of the manuscript before submission and following peer review.

Corresponding author

Correspondence to Ricky A. Sharma.

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R.A.S. declares that he has been the principal investigator for unrestricted educational grants from Sirtex. The other authors declare no competing interests.

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Franklin, J., Gebski, V., Poston, G. et al. Clinical trials of interventional oncology—moving from efficacy to outcomes. Nat Rev Clin Oncol 12, 93–104 (2015). https://doi.org/10.1038/nrclinonc.2014.199

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