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...
Main Authors: | Jiyu Kim, Andrea B. Troxel, Scott D. Halpern, Kevin G. Volpp, Brennan C. Kahan, Tim P. Morris, Michael O. Harhay |
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Format: | Article |
Language: | English |
Published: |
BMC
2020-11-01
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Series: | Trials |
Subjects: | |
Online Access: | http://link.springer.com/article/10.1186/s13063-020-04801-5 |
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