Nevin Manimala Statistics

Using surrogate information to improve confirmatory platform trial with sample size re-estimation

J Biopharm Stat. 2022 Jun 17:1-20. doi: 10.1080/10543406.2022.2080693. Online ahead of print.


Platform design which allows exploring multiple arms with a common control simultaneously is becoming essential for efficient drug development. However, one of the critical challenges for confirmatory platform trials is immature data for interim decisions, particularly for the treatment arm selection and sample size determination with limited data available. We use a modified conditional power (CP) for both treatment arm selection and sample size determination at interim analysis for the proposed platform trial. The modified CP uses the available data from both primary and surrogate endpoints. We also demonstrated the application in a case study of a lung cancer trial.

PMID:35714331 | DOI:10.1080/10543406.2022.2080693

By Nevin Manimala

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