Adaptive Clinical Trial Designs with Endpoint Selection and Sample Size Reassessment
corr_rest
corr_rest_ub: computes the correlation restrictions unblinded case
Endpoint selection and sample size reassessment for composite endpoint...
Endpoint selection and sample size reassessment for composite endpoint...
Simulation trials with endpoint selection and sample size reassessment...
Simulation trials with endpoint selection and sample size reassessment...
Blinded estimation of the correlation
Unblinded estimation of the correlation
f_OR
Simulation 2x2 table binary endpoints
fun_p0
OR_function
samplesize_OR
test_f
test_me
Endpoint selection and sample size reassessment for multiple binary endpoints based on blinded and/or unblinded data. Trial design that allows an adaptive modification of the primary endpoint based on blinded information obtained at an interim analysis. The decision rule chooses the endpoint with the lower estimated required sample size. Additionally, the sample size is reassessed using the estimated event probabilities and correlation between endpoints. The implemented design is proposed in Bofill Roig, M., Gómez Melis, G., Posch, M., and Koenig, F. (2022). <doi:10.48550/arXiv.2206.09639>.