ESMO-MCBS field testing and peer review of version 1.1
The ESMO-MCBS is designed to be a dynamic tool with planned revisions and updates based upon recognition of expanding needs and shortcomings identified
The first version 1.0 of ESMO-MCBS was published in May 2015 and is currently being applied by ESMO in the grading of all new medications or indications of approved anti-neoplastic treatments in solid tumours by the EMA in 2016. These grades are currently being presented in relevant ESMO Clinical Practice Guidelines or as an ‘eUpdate’, where we can rapidly inform of any changes and updates incorporating the ESMO-MCBS grade.
In the next weeks we will be field testing and peer reviewing version 1.1 of the ESMO-MCBS with the collaboration of the ESMO Faculty, who were critical in the development of version 1.0. The ESMO Faculty will be asked to review 8 proposed revisions and the implementation of a new form devised for single arm studies in ‘orphan diseases’ and for diseases with ‘high unmet need’.
The aim of this field test is to ensure that the development of ESMO-MCBS continues to be compliant with the criteria for ‘accountability for reasonableness’1.
The field testing will be completed using Qualtrics (a validated research tool) and will be conducted in two phases the first phase will be to review for reasonableness the new Form 3 and the second phase to review the 8 proposed revisions to the existing forms. The field testing will close on the 20 January 2017.
If you are interested to be part of this field test, please contact Nicola Latino.
The results from this field test aim to be published in Annals of Oncology.
1 Cherny NI, Sullivan R, Dafni U et al. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Ann Oncol 2015; 26: 1547-1573