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goldilocks (version 0.3.0)

goldilocks: goldilocks

Description

The goal of goldilocks is to implement the Goldilocks Bayesian adaptive design proposed by Broglio et al. (2014) for time-to-event endpoint trials, both one- and two-arm, with an underlying piecewise exponential hazard model. The method can be used for a confirmatory trial to select a trial's sample size based on accumulating data. During accrual, frequent sample size selection analyses are made and predictive probabilities are used to determine whether the current sample size is sufficient or whether continuing accrual would be futile. The algorithm explicitly accounts for complete follow-up of all patients before the primary analysis is conducted. Broglio et al. (2014) refer to this as a Goldilocks trial design, as it is constantly asking the question, <U+201C>Is the sample size too big, too small, or just right?<U+201D>

Arguments

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<U+2013>705.