bbssr
Tools for blinded sample size re-estimation (BSSR) in two-arm clinical trials with binary endpoints, together with the exact power and sample size calculations that the re-estimation relies on. Five exact statistical tests are implemented: Pearson chi-squared, Fisher exact, Fisher mid-p, Z-pooled exact unconditional, and Boschloo exact unconditional. Each test is available with a one-sided or a two-sided alternative, and the exact unconditional tests can be combined with the Berger-Boos procedure. Sample sizes can be re-estimated either at the planning stage, to study the operating characteristics of a design, or from the blinded data of a trial that is under way. Statistical methods based on Mehrotra et al. (2003) <doi:10.1111/1541-0420.00051>, Berger and Boos (1994) <doi:10.1080/01621459.1994.10476836> and Kieser (2020) <doi:10.1007/978-3-030-49528-2_21>.
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