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Uses and limitations of randomization-based efficacy estimatorsMRC Biostatistics Unit, Cambridge, UK, ian.white{at}mrc-bsu.cam.ac.uk 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.
Statistical Methods in Medical Research, Vol. 14, No. 4,
327-347 (2005) This article has been cited by other articles:
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