Optimal designs for phase II/III drug development programs including methods for discounting of phase II results

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...

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Bibliographic Details
Main Authors: Stella Erdmann, Marietta Kirchner, Heiko Götte, Meinhard Kieser
Format: Article
Language:English
Published: BMC 2020-10-01
Series:BMC Medical Research Methodology
Subjects:
Optimization
Drug development program
Bias adjustment
Assurance
Probability of success
Sample size
Online Access:http://link.springer.com/article/10.1186/s12874-020-01093-w

Internet

http://link.springer.com/article/10.1186/s12874-020-01093-w

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