TY - JOUR
T1 - Samples in randomized clinical trials with interim analysis
AU - Saaibi Meléndez, Michelle
AU - Botero-Rodríguez, Felipe
AU - Rincón Rodríguez, Carlos Javier
N1 - Publisher Copyright:
© 2023, Instituto Nacional de Salud. All rights reserved.
PY - 2023/4/1
Y1 - 2023/4/1
N2 - 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 ma-thematical 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.
AB - 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 ma-thematical 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.
KW - Clinical Trials
KW - Hypothesis Tests
KW - Sample Size
UR - http://www.scopus.com/inward/record.url?scp=85172377187&partnerID=8YFLogxK
U2 - 10.17843/rpmesp.2023.402.12217
DO - 10.17843/rpmesp.2023.402.12217
M3 - Article
C2 - 38232269
AN - SCOPUS:85172377187
SN - 1726-4634
VL - 40
SP - 220
EP - 228
JO - Revista Peruana de Medicina Experimental y Salud Publica
JF - Revista Peruana de Medicina Experimental y Salud Publica
IS - 2
ER -