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Clinical vs Statistical Significance — SCE Medical Oncology MCQ

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EasyClinical Trials & StatisticsClinical vs Statistical SignificanceSCE Medical Oncology

A phase III trial reports a hazard ratio for overall survival of 0.80 (95% CI 0.68-0.94, p=0.006). The median OS is 14 months in the experimental arm versus 12 months in the control arm. The trial meets its primary endpoint. However, clinical experts debate whether the treatment should be adopted. What is the main concern?

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Correct answer: C — A 2-month improvement in median OS may not be clinically meaningful despite statistical significance — clinical significance and statistical significance are different concepts

Statistical significance (p<0.05) does not automatically confer clinical significance. A statistically significant but small absolute OS benefit (2 months) must be weighed against treatment toxicity, quality of life impact, cost, and patient preferences. NICE uses cost-effectiveness analysis (ICER/QALY) to determine whether a statistically significant benefit is worth funding. The 'minimal clinically important difference' is a key concept in treatment evaluation.

Reference: JRCPTB Medical Oncology Curriculum; NICE Methods Guide for Technology Appraisals