OptOTrials-package: Optimal Two-Stage Designs for Ordered Categorical Outcomes

In OptOTrials: Optimal Two-Stage Designs for Ordered Categorical Outcomes

Optimal Two-Stage Designs for Ordered Categorical Outcomes

Description

Functions to design and simulate optimal two-stage randomized controlled trials (RCTs) with ordered categorical outcomes, supporting rank-based tests and group-sequential decision rules. Methods build on classical and modern rank tests and two-stage/Group-Sequential designs, e.g., Park (2025) <doi: 10.1371/journal.pone.0318211>. Please see the package reference manual and vignettes for details.

Details

There are several main functoins. Decision_rule_S_1stage, Decision_rule_M_1stage, Decision_rule_W_1stage, ruleF, and ruleFS determine the decision rule for clinical trials. op.1stage, op.F, and op.FS calculate the operating characteristics for clinical trial designs, including type I error, power, and expected sample size, to investigate the performance of the designs.

Author(s)

Yeonhee Park [aut, cre], Yudi Wang [aut], Zhanpeng Xu [aut]

Maintainer: Yeonhee Park <[e-mail]>

References

Park, Y. (2025). Optimal two-stage group sequential designs based on Mann-Whitney-Wilcoxon test. PloS one, 20(2), e0318211.

OptOTrials documentation built on Sept. 9, 2025, 5:46 p.m.