PASSReviewer 1· 85% conf
The study design is adequately described for a phase II platform trial, including randomization method, stratification, and eligibility criteria, though power analysis is not applicable as it is not powered for comparative statistics.
Evidence
direct quote[Methods, Study design]
“A blocked randomization was generated, and randomization was balanced within the IRT at the central level.”direct quote[Methods, Study design]
“NeoCOAST-2 is a phase II, open-label, multiarm, multicenter, global, randomized platform study.”direct quote[Methods, Statistical analysis]
“The sample size was not based on type I error and power considerations.”PASSReviewer 2· 85% conf
The study design is adequately described for a phase II platform trial, including randomization, stratification, and eligibility criteria, though blinding is not applicable (open-label) and power analysis is not based on type I error.
Evidence
direct quote[Methods, Study design]
“A randomization method featuring a dynamically changing allocation ratio for treatment assignments was used to account for fluctuations in the number of patients enrolled in the treatment arms over the course of the study”direct quote[Methods, Study design]
“NeoCOAST-2 is a phase II, open-label, multiarm, multicenter, global, randomized platform study.”paraphrase[Methods, Statistical analysis]
“The sample size was not based on type I error and power considerations. Instead, it was based on the model-based drug development approach.”