Many analyses of observational data are attempts to emulate a target trial. The emulation of the target trial may fail when researchers deviate from simple principles that guide the design and analysis of randomized experiments. We review a framework to describe and prevent biases, including immortal time bias, that result from a failure to align start of follow-up, specification of eligibility, and treatment assignment. We review some analytic approaches to avoid these problems in comparative effectiveness or safety research.
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Published online: May 27, 2016
Accepted: April 23, 2016
Funding: This research was partly funded by NIH grant P01 CA134294.
Conflict of interest: None of the authors report any conflict of interest.
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