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ITT Principle — SCE Medical Oncology MCQ

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EasyClinical Trials & StatisticsITT PrincipleSCE Medical Oncology

A clinical trial uses the 'intention-to-treat' (ITT) principle for its primary analysis. Some patients randomised to the experimental arm never received the drug due to rapid deterioration. They are still included in the analysis. Why?

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Correct answer: E — ITT preserves the benefits of randomisation (balanced prognostic factors) and prevents bias from selective exclusion — excluding non-compliant patients would introduce selection bias because the reasons for non-compliance (e.g. rapid deterioration) are often related to prognosis

ITT: all randomised patients analysed in their assigned group regardless of compliance, crossover or protocol violations. Preserves randomisation benefits (eliminates confounding). Gives a conservative/real-world estimate. Per-protocol analysis (compliant patients only) is a sensitivity analysis estimating the treatment effect under ideal adherence. Both should be reported; ITT is the primary regulatory analysis.

Reference: JRCPTB; ICH E9; CONSORT