Optimal designs for phase II/III drug development programs including methods for discounting of phase II results
Abstract Background Go/no-go decisions after phase II and sample size chosen for phase III are usually based on phase II results (e.g., the treatment effect estimate of phase II). Due to the decision rule (only promising phase II results lead to phase III), treatment effect estimates from phase II t...
Main Authors: | , , , |
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Format: | Article |
Language: | English |
Published: |
BMC
2020-10-01
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Series: | BMC Medical Research Methodology |
Subjects: | |
Online Access: | http://link.springer.com/article/10.1186/s12874-020-01093-w |