Abstract
Impact of lack-of-benefit stopping rules on treatment effect estimates of two-arm multi-stage (TAMS) trials with time to event outcome
Highlights
In 2011, Royston et al described technical details of a two-arm, multi-stage (TAMS) design
In TAMS designs, the stopping rule applied at the interim stage(s) affects the sampling distribution of the treatment effect estimator, potentially inducing bias that needs addressing
Using simulations, we quantified the bias in the treatment effect estimator in TAMS trials for different designs
Summary
In 2011, Royston et al described technical details of a two-arm, multi-stage (TAMS) design. Impact of lack-of-benefit stopping rules on treatment effect estimates of two-arm multi-stage (TAMS) trials with time to event outcome Babak Choodari-Oskooei1*, Max KB Parmar1, Patrick Royston1, Jack Bowden2 From 2nd Clinical Trials Methodology Conference: Methodology Matters Edinburgh, UK.
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