ORIGINAL RESEARCH article
Front. Appl. Math. Stat.
Sec. Statistics and Probability
Volume 11 - 2025 | doi: 10.3389/fams.2025.1611205
GSD-SSR: An Integrated Framework for Power Analysis in IRB Proposals Using Group Sequential Design and Sample Size Re-estimation
Provisionally accepted
- 1Department of Pediatrics, Rainbow Babies & Children's Hospital, Cleveland, Ohio, United States
- 2International College of Pharmaceutical Innovation, Soochow University, Suzhou, Jiangsu Province, China
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Accurate sample size estimation is a cornerstone of successful Institutional Review Board (IRB) proposals, as it establishes the feasibility of clinical studies and ensures they are sufficiently powered to detect meaningful effects. Underestimating sample size poses the risk of insufficient statistical power, compromising the ability to identify significant outcomes. Conversely, overestimating sample size can lead to prolonged data collection, wasting valuable time and resources.One of the primary challenges in sample size estimation lies in the uncertainty surrounding variance and effect size before the study begins. Group Sequential Design with Sample Size Reestimation (GSD-SSR) effectively addresses this issue by utilizing interim data at predefined stages to refine these estimates. GSD-SSR enables dynamic adjustments to sample size during the study, optimizing resource allocation and improving overall efficiency.We offer a comprehensive introduction to the theoretical background of GSD-SSR and provide step-by-step guidance for its practical application in clinical research. To further facilitate adoption, we have developed a user-friendly online platform that streamlines the GSD-SSR process and integrates it seamlessly into IRB proposals. By incorporating GSD-SSR into the power analysis of IRB proposals, researchers can significantly increase the likelihood of successful clinical studies while enhancing budget efficiency and optimizing timelines.
Keywords: Sample size calculation, Group sequential design, sample size re-estimation, power analysis, Clinical Trial
Received: 14 Apr 2025; Accepted: 24 Jun 2025.
Copyright: © 2025 Zhu, xia and Du. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Yuxi Zhu, Department of Pediatrics, Rainbow Babies & Children's Hospital, Cleveland, Ohio, United States
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