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Stat Methods Med Res. 2005 Aug;14(4):327-47.

Uses and limitations of randomization-based efficacy estimators.

Author information

1
MRC Biostatistics Unit, Institute of Public Health, Robinson Way, Cambridge CB2 2SR, UK. ian.white@mrc-bsu.cam.ac.uk

Abstract

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.

PMID:
16178136
DOI:
10.1191/0962280205sm406oa
[Indexed for MEDLINE]

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