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DTEBOP2 - Bayesian Optimal Phase II Randomized Clinical Trial Design with Delayed Outcomes

Implements a Bayesian Optimal Phase II design (DTE-BOP2) for trials with delayed treatment effects, particularly relevant to immunotherapy studies where treatment benefits may emerge after a delay. The method builds upon the BOP2 framework and incorporates uncertainty in the delay timepoint through a truncated gamma prior, informed by expert knowledge or default settings. Supports two-arm trial designs with functionality for sample size determination, interim and final analyses, and comprehensive simulation under various delay and design scenarios. Ensures rigorous type I and II error control while improving trial efficiency and power when the delay effect is present. A manuscript describing the methodology is under development and will be formally referenced upon publication.

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2.00 score 1 stars 529 downloads

WCRBayesDesign - Bayesian Two-Stage Design with Window-Cohort and Controlled Roll-on for Time-to-Event Estimand

Calibrates Bayesian two-stage designs for single-arm phase II trials with time-to-event endpoints using a window-cohort with controlled roll-on. Interim monitoring is anchored to a locked interim cohort and a pre-specified follow-up requirement, so analysis timing remains predictable while preserving follow-up maturity. The package searches feasible interim rules, optimizes final sample size and decision thresholds, evaluates operating characteristics by Monte Carlo simulation, and supports exponential, Weibull, log-normal, log-logistic, and user-defined baseline survival models. Related published foundations include Simon (1989) <doi:10.1016/0197-2456(89)90015-9> and Cotterill and Whitehead (2015) <doi:10.1002/sim.6426>.

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1.70 score 418 downloads