Statistical considerations of phase 3 umbrella trials allowing adding one treatment arm mid-trial
Abstract
Master protocols, in particular umbrella trials and platform trials, when evaluating multiple experimental treatments with a common control, could save patient resource, increase trial efficiency, and reduce drug development cost. Compared to the phase 3 platform trials that allow unlimited number of experimental arms to be added, it is more practical for individual companies to evaluate two experimental arms with a common control in an umbrella...
Paper Details
Title
Statistical considerations of phase 3 umbrella trials allowing adding one treatment arm mid-trial
Published Date
Oct 1, 2021
Journal
Volume
109
Pages
106538 - 106538
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