ESMO-MCBS bias clinical trial design clinical trial implementation clinical trial reporting clinical trial analysis

Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scoring

by B. Gyawali, E. G. E. de Vries, U. Dafni, T. Amaral, J. Barriuso, J. Bogaerts, A. Calles, G. Curigliano, C. Gomez-Roca, B. Kiesewetter, S. Oosting, A. Passaro, G. Pentheroudakis, M. Piccart, F. Roitberg, J. Tabernero, N. Tarazona, D. Trapani, R. Wester, G.

Apr 20^th 2021
8 mins
ESMO: Volume 6, Issue 3, 100117, June 2021

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Summary

The ESMO-MCBS is a tool used for scoring the clinical benefit of cancer medicines as reported in clinical trials, assuming valid research methodologies and quality implementation.
The tool's effectiveness is compromised by studies with flawed design, implementation, or data analysis, which can exaggerate outcomes and lack generalizability.
A review was conducted to assess the ESMO-MCBS's ability to address biases from such flawed studies and identify areas needing improvement.
The review compared ESMO-MCBS's approach to several ethical and technical guidelines, including those from the Helsinki guidelines, International Council for Harmonisation, FDA, EMA, and ENHTA.
Ten issues were evaluated (six design, two implementation, and two data analysis), with the ESMO-MCBS adequately addressing three.
Seven shortcomings were identified in ESMO-MCBS's handling of bias, covering control arm evaluation, crossover issues, non-inferiority criteria, substandard post-progression treatment, post hoc subgroup findings, informative censoring, and publication bias against quality-of-life data.
Future iterations of the ESMO-MCBS will address these issues, emphasizing the need for a critical appraisal of trial designs, implementations, and data analyses when interpreting scores.

The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) was first published in 2015 and revised in 2017. With a growing recognition that many cancer medicines provided modest benefits disproportionate to their high costs, the oncology community needed a tool that could objectively assess the clinical benefit from cancer medicines, assist in comparison with other similar medicines, and guide regulatory and reimbursement decisions. The ESMO-MCBS was established to address these needs. To reduce bias and error in grading, the scale has been developed in close adherence to the principles of ‘accountability for reasonableness’, a standard for ethical public health decision-making processes.

The ESMO-MCBS aims to highlight treatments with a substantial level of clinical benefit for patients and distinguish those from studies demonstrating only moderate, minor, or marginal clinical benefit. Within ESMO, the ESMO-MCBS is used in clinical practice guidelines and provides a structured approach to evaluate clinical research data. On its website, ESMO has an open access searchable portal detailing >230 clinical studies (Scorecards) assessed using the ESMO-MCBS. Internationally, a high ESMO-MCBS score is currently valued and adopted by the World Health Organization Essential Medicines List (WHO EML) and Health Technology Assessment b odies worldwide. These global health applications underscore the importance of the ESMO-MCBS commitments to ‘accountability for reasonableness’ and continual efforts to improve the scoring process’s validity.

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ESMO-MCBS, bias, clinical trial design, clinical trial implementation, clinical trial reporting, clinical trial analysis

Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scoring

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