In a clinical trial, 'intention-to-treat' (ITT) analysis means:
- A Analysis includes only participants who completed the full protocol
- B All randomised participants are analysed in the group to which they were assigned, regardless of compliance ✓
- C Analysis is restricted to participants who intended to comply with treatment
- D Participants crossing over to the other arm are excluded
Correct answer: B. All randomised participants are analysed in the group to which they were assigned, regardless of compliance
Explanation
ITT analysis maintains the integrity of randomisation by analysing all participants in their originally allocated group, including those who dropped out, crossed over, or were non-compliant. This prevents selection bias that occurs when excluding non-compliant participants (per-protocol analysis), which tends to overestimate efficacy. ITT provides a conservative but unbiased estimate of the effectiveness under real-world conditions.
Reference: Park's Textbook of Preventive and Social Medicine, 27th ed.
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