On estimating treatment effects under non‐compliance in randomized clinical trials: are intent‐to‐treat or instrumental variables analyses perfect solutions?

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Abstract
In this report, we compared four estimators (intent‐to‐treat, as treated, per protocol, and instrumental variables estimators) that are conventionally considered for treatment effect estimation by simulation under different non‐compliance scenarios in typical clinical trial settings. We found that intent‐to‐treat and instrumental variables estimators are not perfect and can be problematic in some situations although these two estimators carry desirable properties as we assume. Copyright © 2006 John Wiley & Sons, Ltd.