J Biopharm Stat. 2024 Jan 2:1-17. doi: 10.1080/10543406.2023.2296054. Online ahead of print.
ABSTRACT
Making the go/no-go decision is critical in Phase II (or Ib) clinical trials. The conventional decision-making framework based on a binary hypothesis testing has been gradually replaced by the TODeM (Triple Outcome Decision-Making) which has three zones of outcomes: go, no-go, and consider. The TODeM provides more flexibility in decision-making with considering both of statistical significance and clinical relevance. However, Bayesian methods (e.g. EXNEX, MUCE, etc.) for the information borrowing are still based on the binary decision-making framework. We propose a new decision-making process G-TODeM (Generalized Triple Outcome Decision-Making) to apply those Bayesian methods with information borrowing across different cohorts to the TODeM framework. Essentially, the information borrowed from other cohorts can shrink the consider zone of the inference cohort.
PMID:38166528 | DOI:10.1080/10543406.2023.2296054
