Journal
DRUG INFORMATION JOURNAL
Volume 40, Issue 4, Pages 445-450Publisher
DRUG INFORMATION ASSOCIATION
DOI: 10.1177/216847900604000410
Keywords
interim analysis; Data Monitoring Committee; unblinded data; seamless design
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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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