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.

Action

Field testing and peer reviewing of version 1.1 of the ESMO-MCBS has just completed with the collaboration of the ESMO Faculty, who were critical in the development of version 1.0. The ESMO Faculty were 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’.

Aim

The aim of the field test was to ensure that the development of ESMO-MCBS continues to be compliant with the criteria for ‘accountability for reasonableness’1.

Survey

The field testing was completed using Qualtrics (a validated research tool) and conducted in two parts the first part was the review for reasonableness of a new Form 3 and the second part was to review 8 proposed revisions to the existing forms.

The field testing was started on the 13 December 2016 and closed on the 20 January 2017 we thank all those who kindly participated.

Results

The results from this field test aim to be published in Annals of Oncology

References

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