group sequential designs;
interim analyses;
workflow chart;
R Code;
tutorial;
CLINICAL-TRIALS;
TESTS;
HAPPY;
D O I:
10.5964/meth.2811
中图分类号:
O1 [数学];
C [社会科学总论];
学科分类号:
03 ;
0303 ;
0701 ;
070101 ;
摘要:
Psychological research is confronted with ever-increasing demands to save resources such as time and money while assuring high ethical standards. In medical and pharmaceutical research, group sequential designs have fundamentally changed traditional statistical testing approaches featuring only one analysis at the end of a single-stage study. They enable early stopping at an interim stage, after a group of observations, for efficacy or futility in case of an overwhelmingly large or small effect, respectively. Otherwise, the trial is continued to the next stage. On average over many studies time and money are saved and more ethical trials are facilitated by diminishing the risk of patients' exposure to inferior treatments. We provide an easy-to-use tutorial for psychological research replete with easily understandable figures highlighting the core idea of different group sequential designs, a workflow chart, an empirical real-world data set, and the annotated R code. Finally, we demonstrate the application of early stopping for efficacy.
机构:
Stanford Univ, Meta Res Innovat Ctr Stanford METRICS, Stanford, CA 94305 USA
Stanford Univ, Dept Med, Stanford, CA 94305 USA
Stanford Univ, Dept Hlth Res & Policy, Stanford, CA 94305 USA
Stanford Univ, Dept Stat, Stanford, CA 94305 USACharite, Dept Biostat & Clin Epidemiol, Berlin, Germany
Ioannidis, John P. A.
Kimmelman, Jonathan
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h-index: 0
机构:
McGill Univ, STREAM Res Grp, Biomed Eth Unit, Montreal, PQ, CanadaCharite, Dept Biostat & Clin Epidemiol, Berlin, Germany
Kimmelman, Jonathan
Dirnagl, Ulrich
论文数: 0引用数: 0
h-index: 0
机构:
Charite, Ctr Stroke Res, Berlin, Germany
Charite, NeuroCure Clin Res Ctr, Berlin, Germany
Charite, Dept Expt Neurol, Berlin, Germany
Berlin Inst Hlth, Ctr Transforming Biomed Res, Berlin, Germany
German Ctr Neurodegenerat Dis DZNE, Berlin Site, Berlin, Germany
German Ctr Cardiovasc Res DZHK, Berlin Site, Berlin, GermanyCharite, Dept Biostat & Clin Epidemiol, Berlin, Germany