Updated ESMO Magnitude of Clinical Benefit Scale set to evaluate single-arm studies
An updated version of the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) will enable users to evaluate single-arm studies for the first time. The ESMO-MCBS version 1.1 is set to be published online in the Annals of Oncology on 5 September 2017.
The ESMO-MCBS version 1.0 was first published in May 2015 in Annals of Oncology. Since 2016 ESMO has been using the scale to grade all new medications or indications of anti-neoplastic treatments in solid tumours approved by the European Medicines Agency and presenting these scores in relevant ESMO Clinical Practice Guidelines or as an 'eUpdate'.
Lead author Prof. Nathan Cherny, Norman Levan Chair of Humanistic Medicine, Shaare Zedek Medical Centre, Jerusalem, Israel, said: "The ESMO-MCBS is an evolving project. We are constantly evaluating the validity and reasonableness of the scoring generated by the ESMO-MCBS, looking to identify and understand problems and seeking ways to improve the scale."
"Version 1.1 is the first major revision," continued Cherny. "It incorporates nine amendments that address shortcomings identified in version 1.0 and introduces a new scale for single-arm studies. So while the first version only scored comparative studies, the updated tool will enable users to evaluate single-arm studies in orphan diseases and for diseases with high unmet need."
Field testing and peer review of version 1.1 of the ESMO-MCBS was conducted in collaboration with the ESMO Faculty and Guidelines Committee, who were critical in the development of version 1.0.
Cherny said: "The ESMO-MCBS has shown itself to be a valued tool for evaluating the magnitude of benefit from clinical studies. Evolving experience, feedback and discussion with users, and published critiques have informed the revised version and we invite users of version 1.1 to provide feedback to assist us in the process of ongoing development and refinement."
Prof. Fortunato Ciardiello, ESMO President, said: "The ESMO-MCBS was designed as a dynamic tool that would be revised based on expanding needs and any shortcomings that were identified. The new version - in particular the ability to score single-arm studies in orphan diseases and for diseases with high unmet need - will go even further in promoting ESMO's mission to deliver sustainable cancer care."
Prof. Elisabeth de Vries, Chair of the ESMO Magnitude of Clinical Benefit Scale Working Group, said: "The recent survey on the awareness and utilisation of the ESMO-MCBS has shown us that as well as being used to derive the magnitude of clinical benefit of medicines it is also being used as an educational tool to train fellows in the interpretation of data from clinical trials and in journal club discussions regarding the efficacy of new treatments."
