Abstract

SAAIBI MELENDEZ, Michelle; BOTERO-RODRIGUEZ, Felipe  and  RINCON RODRIGUEZ, Carlos Javier. Samples in randomized clinical trials with interim analysis. Rev. perú. med. exp. salud publica [online]. 2023, vol.40, n.2, pp.220-228.  Epub June 30, 2023. ISSN 1726-4634.  http://dx.doi.org/10.17843/rpmesp.2023.402.12217.

This article introduces randomized clinical trials and basic concepts of statistical inference. We present methods for calculating the sample size by outcome type and the hypothesis to be tested, together with the code in the R programming language. We describe four methods for adjusting the original sample size for interim analyses. We sought to introduce these topics in a simple and concrete way, considering the mathematical expressions that support the results and their implementation in available statistical programs; therefore, bringing health students closer to statistics and the use of statistical programs, which are aspects that are rarely considered during their training.

Keywords : Sample Size; Clinical Trials; Hypothesis Tests.

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