Abstract
Adaptive design trials raise important issues regarding processes for review of interim data and implementation of adaptation decisions, while avoiding bias and maintaining interpretability of trial results. We discuss the issues, distinctions versus more familiar monitoring situations, various aspects of operational models for data monitoring, and types of adaptations that may be more or less prone to concerns about bias.
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Paul P. Gallo has disclosed that he is an employee of Novartis Pharmaceuticals Corporation.
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Gallo, P. Confidentiality and Trial Integrity Issues for Adaptive Designs. Ther Innov Regul Sci 40, 445–450 (2006). https://doi.org/10.1177/216847900604000410
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DOI: https://doi.org/10.1177/216847900604000410