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Statistical methods for clinical trials


Bayesian design for phase II trials
The WebApp BDP2 provides a workflow to determine design parameters for a multi-stage single-arm phase II trial with binary endpoint. Declaration of efficacy and futility is based on the Bayesian posterior distribution. It is based on the R-package BDP2 available from CRAN.
For details see:
Kopp‐Schneider, A., Wiesenfarth, M., Witt, R., Edelmann, D., Witt, O., & Abel, U. (2019). Monitoring futility and efficacy in phase II trials with Bayesian posterior distributions - A calibration approach. Biometrical Journal, 61(3), 488-502.


Sample size calculation for modifications of Simon's two-stage design
The R package hctrial can be used to calculate the sample size for modifications of Simon's two stage design allowing for stratification and incorporation of historical controls.
For details see:
Edelmann, D., Habermehl, C., Schlenk, R. F., & Benner, A. (2020). Adjusting Simon's optimal two‐stage design for heterogeneous populations based on stratification or using historical controls. Biometrical Journal, 62(2), 311-329.


Sample size determination for diagnostic studies
The WebApp SampleSizeDiagnosticTest can be used to estimate the sample size for a study where the aim is to test whether the performance of a diagnostic test is sufficient in terms of false positive (specificity) and true positive fraction (sensitivity).

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