An analysis of phase III trial results published between 2011–2015 using the European Society of Medical Oncology (ESMO)–magnitude of clinical benefit scale (MCBS) indicates that only 31% of treatments that resulted in statistically significant improvements in outcomes met the thresholds for clinical benefit. Investigators also found that fewer than half of the trials analysed were even designed to detect an effect size deemed to confer benefit according to the ESMO–MCBS criteria. These observations indicate a need for more stringent trial designs and use of clinical benefit thresholds.
References
Del Paggio, J. C. et al. Do contemporary randomized controlled trials meet ESMO thresholds for meaningful clinical benefit?. Ann. Oncol. http://dx.doi.org/10.1093/annonc/mdw538 (2016).
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Sidaway, P. Does significance indicate clinical benefit?. Nat Rev Clin Oncol 14, 3 (2017). https://doi.org/10.1038/nrclinonc.2016.175
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DOI: https://doi.org/10.1038/nrclinonc.2016.175