TAD-SIE: sample size estimation for clinical randomized controlled trials using a Trend-Adaptive Design with a Synthetic-Intervention-Based Estimator

Abstract Background Phase-3 clinical trials provide the highest level of evidence on drug safety and effectiveness needed for market approval by implementing large randomized controlled trials (RCTs). However, 30–40% of these trials fail mainly because such studies have inadequate sample sizes, stem...

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Bibliographic Details
Main Authors: Sayeri Lala, Niraj K. Jha
Format: Article
Language:English
Published: BMC 2025-01-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-024-08661-1
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