Point estimation for adaptive trial designs I: a methodological review

URN to cite this document:: urn:nbn:de:bvb:355-epub-778436
DOI to cite this document:: 10.5283/epub.77843

Robertson, David S. ; Choodari‐Oskooei, Babak ; Dimairo, Munya ; Flight, Laura ; Pallmann, Philip ; Jaki, Thomas

License: Creative Commons Attribution 4.0
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Date of publication of this fulltext: 29 Sep 2025 06:12

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Abstract

Recent FDA guidance on adaptive clinical trial designs defines bias as “a systematic tendency for the estimate of treatment effect to deviate from its true value,” and states that it is desirable to obtain and report estimates of treatment effects that reduce or remove this bias. The conventional end-of-trial point estimates of the treatment effects are prone to bias in many adaptive designs, ...