The impact of lowering the study design significance threshold to 0.005 on sample size in randomized cancer clinical trials.

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2024-01

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Abstract

The proposal of improving reproducibility by lowering the significance threshold to 0.005 has been discussed, but the impact on conducting clinical trials has yet to be examined from a study design perspective. The impact on sample size and study duration was investigated using design setups from 125 phase II studies published between 2015 and 2022. The impact was assessed using percent increase in sample size and additional years of accrual with the medians being 110.97% higher and 2.65 years longer respectively. The results indicated that this proposal causes additional financial burdens that reduce the efficiency of conducting clinical trials.

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Journal article

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P-value, clinical trial, sample size, threshold, trial design

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https://hdl.handle.net/10161/30405

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https://creativecommons.org/licenses/by-nc/4.0

Published Version (Please cite this version)

10.1017/cts.2023.699

Publication Info

Leung, Tiffany H, James C Ho, Xiaofei Wang, Wendy W Lam and Herbert H Pang (2024). The impact of lowering the study design significance threshold to 0.005 on sample size in randomized cancer clinical trials. Journal of clinical and translational science, 8(1). p. e9. 10.1017/cts.2023.699 Retrieved from https://hdl.handle.net/10161/30405.

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Scholars@Duke

Wang

Xiaofei Wang

Professor of Biostatistics & Bioinformatics

Design and Analysis of Clinical Trials
Methods for Diagnostic and Predictive Medicine
Survival Analysis
Causal Inference
Analysis of Data from Multiple Sources


Pang

Herbert Pang

Adjunct Assistant Professor in the Department of Biostatistics & Bioinformatics

Classification and Predictive Models
Design and Analysis of Biomarker Clinical Trials
Genomics
Pathway Analysis

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