Samples in randomized clinical trials with interim analysis

Authors

  • Michelle Saaibi Meléndez Semillero de Bioestadística, Facultad de Medicina, Pontificia Universidad Javeriana, Bogotá, Colombia. Departamento de Epidemiología Clínica y Bioestadística, Pontificia Universidad Javeriana, Bogotá, Colombia https://orcid.org/0000-0001-5211-1456
  • Felipe Botero-Rodríguez Semillero de Bioestadística, Facultad de Medicina, Pontificia Universidad Javeriana, Bogotá, Colombia. Departamento de Epidemiología Clínica y Bioestadística, Pontificia Universidad Javeriana, Bogotá, Colombia https://orcid.org/0000-0003-1537-5211
  • Carlos Javier Rincón Rodríguez Semillero de Bioestadística, Facultad de Medicina, Pontificia Universidad Javeriana, Bogotá, Colombia. Departamento de Epidemiología Clínica y Bioestadística, Pontificia Universidad Javeriana, Bogotá, Colombia https://orcid.org/0000-0002-0477-1908

DOI:

https://doi.org/10.17843/rpmesp.2023.402.12217

Keywords:

Sample Size, Clinical Trials, Hypothesis Tests

Abstract

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.

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Published

2023-06-30

Issue

Section

Special Section

How to Cite

1.
Saaibi Meléndez M, Botero-Rodríguez F, Rincón Rodríguez CJ. Samples in randomized clinical trials with interim analysis. Rev Peru Med Exp Salud Publica [Internet]. 2023 Jun. 30 [cited 2024 Jun. 18];40(2):220-8. Available from: https://rpmesp.ins.gob.pe/index.php/rpmesp/article/view/12217

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