Analysis of multicenter clinical trials with very low event rates

Analysis of multicenter clinical trials with very low event rates

Abstract Introduction In a five-arm randomized clinical trial (RCT) with stratified randomization across 54 sites, we encountered low primary outcome event proportions, resulting in multiple sites with zero events either overall or in one or more study arms. In this paper, we systematically evaluate...

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Bibliographic Details
Main Authors: Jiyu Kim, Andrea B. Troxel, Scott D. Halpern, Kevin G. Volpp, Brennan C. Kahan, Tim P. Morris, Michael O. Harhay
Format: Article
Language:English
Published: BMC 2020-11-01
Series:Trials
Subjects:
Multicenter trial
Binary outcomes
Low event rate
Randomized clinical trial
Random effects
GEE
Online Access:http://link.springer.com/article/10.1186/s13063-020-04801-5

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http://link.springer.com/article/10.1186/s13063-020-04801-5

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