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Implements the Goldilocks Bayesian adaptive design proposed by Broglio et al. (2014) for single-arm and randomized two-arm trials. Outcomes are generated with an underlying piecewise-exponential event-time model. Final analyses may retain the time-to-event outcome (method = "logrank", "cox", "rmst", or "bayes-surv") or reduce complete follow-up to event status at a fixed endpoint time (method = "riskdiff-wald", "riskdiff-fm", or "bayes-bin").

The method can be used for a confirmatory trial to select a sample size based on accumulating data. During accrual, predictive probabilities are used to determine whether the current sample size is sufficient, whether continuing accrual would be futile, or whether enrollment should continue. The algorithm explicitly accounts for completion of planned follow-up before the primary analysis. Broglio et al. (2014) refer to this as a Goldilocks trial design, as it is constantly asking the question, “Is the sample size too big, too small, or just right?”

References

Broglio KR, Connor JT, Berry SM. Not too big, not too small: a Goldilocks approach to sample size selection. Journal of Biopharmaceutical Statistics, 2014; 24(3): 685–705.