CompAREdesign - Statistical Functions for the Design of Studies with Composite Endpoints

It has been designed to calculate the required sample size in randomized clinical trials with composite endpoints. It also calculates the expected effect and the probability of observing the composite endpoint, among others. The methodology can be found in Bofill & Gómez (2019) <doi:10.1002/sim.8092> and Gómez & Lagakos (2013) <doi:10.1002/sim.5547>.

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2.95 score 1 dependents 2 scripts 201 downloads

survmixer - Design of Clinical Trials with Survival Endpoints Based on Binary Responses

Sample size and effect size calculations for survival endpoints based on mixture survival-by-response model. The methods implemented can be found in Bofill, Shen & Gómez (2021) <arXiv:2008.12887>.

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2.70 score 176 downloads

eselect - Adaptive Clinical Trial Designs with Endpoint Selection and Sample Size Reassessment

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>.

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1.00 score 210 downloads