The article in ESMO Open addresses the methodology behind the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) and provides a detailed statistical assessment.
Grading is guided by a dual rule comparing the relative benefit (RB) and the absolute benefit (AB) achieved by the therapy to prespecified threshold values. The ESMO-MCBS v1.0 dual rule evaluates the RB of an experimental treatment based on the lower limit of the 95%CI (LL95%CI) for the hazard ratio (HR) along with an AB threshold.
This dual rule addresses two goals:
- Inclusiveness - not unfairly penalising experimental treatments from trials designed with adequate power targeting clinically meaningful relative benefit;
- Discernment - penalising trials designed to detect a small inconsequential benefit.
To view the article please visit ESMO Open website