Journal
STATISTICAL METHODS IN MEDICAL RESEARCH
Volume 14, Issue 4, Pages 327-347Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1191/0962280205sm406oa
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In randomized trials with departures from allocated treatment, intention-to-treat analysis is important but not always sufficient. The most common supplement to intention-to-treat analysis is per-protocol analysis, whose assumption of comparability between different nonrandomized groups is often implausible. Randomization-based methods avoid making this assumption and are preferable. Situations where intention-to-treat analysis is insufficient and a randomization-based method is useful include provision of patient information, exploration of treatment - covariate and treatment - time interactions, meta-analysis, and equivalence trials.
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