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July 29, 2026 evidence esmo clinical-trials

Statistically significant is not automatically worthwhile

ESMO-MCBS scores the size of benefit in studies that are already statistically positive. Its purpose is to distinguish a small, formal effect from one likely to matter to patients.

Written retrospectively and published on August 3, 2026.

Background reading, not clinical guidance. This describes published research; it is not a recommendation for any individual case, and the cited studies may have been superseded.

A p-value can say that an observed difference is unlikely to be due to chance under a statistical model. It does not say whether the difference is large enough to change a person’s experience, time without disease progression, or survival in a meaningful way.

ESMO created its Magnitude of Clinical Benefit Scale for that second question. It is applied to trials that have already met their formal positive criterion. The scale then considers relative effect, absolute gain, quality of life and toxicity, using different forms for different trial designs.

A positive trial can receive the lowest non-curative score

In the survival-based forms, a large-looking relative effect is not enough: the observed median gain must also clear a minimum threshold. This design intentionally downgrades statistically significant results with clinically trivial benefit.

For example, a pancreatic-cancer trial of gemcitabine plus erlotinib reported a statistically significant survival difference of about ten days. The example does not invalidate the trial; it illustrates why “significant” and “substantial” are separate claims.

Thresholds depend on the ESMO-MCBS version and the trial form. Any exact score should therefore state the version used.

Sources

  1. Cherny NI, Sullivan R, Dafni U, et al. A standardised, generic, validated approach to stratify the magnitude of clinical benefit anticipated from anti-cancer therapies: ESMO-MCBS. Annals of Oncology. 2015. · 10.1093/annonc/mdv249
  2. Cherny NI, Oosting SF, Dafni U, et al. ESMO Magnitude of Clinical Benefit Scale version 2.0. Annals of Oncology. 2025. · 10.1016/j.annonc.2025.04.006
  3. Moore MJ, Goldstein D, Hamm J, et al. Erlotinib plus gemcitabine compared with gemcitabine alone in advanced pancreatic cancer. JCO. 2007. · 10.1200/JCO.2006.07.9525

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