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Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit?

J C Del Paggio1, B Azariah2, R Sullivan3

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Annals of Oncology : Official Journal of the European Society for Medical Oncology
|October 16, 2016
PubMed
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Few cancer clinical trials meet the European Society for Medical Oncology

Keywords:
ESMO-MCBSbenefitmeaningfulvalue

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Area of Science:

  • Oncology
  • Clinical Trials
  • Translational Research

Background:

  • The European Society for Medical Oncology (ESMO) developed a scale to assess the clinical benefit of systemic therapies for solid tumors.
  • Evaluating contemporary randomized controlled trials (RCTs) against these thresholds is crucial for understanding treatment efficacy.

Purpose of the Study:

  • To assess how many contemporary randomized controlled trials (RCTs) meet the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) thresholds for meaningful clinical benefit.
  • To determine if RCTs were designed to detect effects meeting ESMO-MCBS criteria.

Main Methods:

  • Systematic review of RCTs for breast, non-small cell lung, colorectal, and pancreatic cancers published 2011-2015.
  • Data abstraction on trial characteristics and outcomes, applied to ESMO-MCBS.
  • Analysis of trial design power to detect ESMO-MCBS-defined benefit.

Main Results:

  • Of 277 RCTs, 50% showed statistically superior experimental therapy, but only 31% of these met ESMO-MCBS thresholds.
  • Trials with curative intent were more likely to meet thresholds (61%) than palliative intent trials (22%).
  • Only 31% of applicable RCTs were designed to detect an effect size meeting ESMO-MCBS thresholds.

Conclusions:

  • Less than one-third of statistically significant cancer RCTs meet ESMO thresholds for meaningful clinical benefit.
  • This highlights a need for more stringent benefit thresholds in the design of future clinical trials.
  • Recommendations for investigators, funding agencies, and industry to adopt higher standards for meaningful benefit.