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Reconsideration of sample size and power calculation for overall survival in cancer clinical trials

Authors
 Inkyung Jung  ;  Hee Jung Ko  ;  Sun Young Rha  ;  Chung Mo Nam 
Citation
 Contemporary Clinical Trials Communications, Vol.12 : 90-91, 2018 
Journal Title
 Contemporary Clinical Trials Communications 
Issue Date
2018
Keywords
Hypo-exponential distribution ; Progression-free survival (PFS) ; Survival post-progression (SPP)
Abstract
When designing a cancer clinical trial, it is usual to assume an exponential distribution for a time-to-event outcome such as overall survival (OS). OS is often expressed as the sum of progression-free survival (PFS) and survival post-progression (SPP), each of which is assumed to be exponentially distributed. Then, OS does not follow an exponential distribution any more but a gamma or hypo-exponential distribution. In this study, we derived a sample size calculation formula for comparing OS between two treatment arms using the log-rank test for OS following a gamma or hypo-exponential distribution. We conducted a simulation study to evaluate the sample size and power calculation based on the gamma or hypo-exponential distribution. We found that we could reduce the sample sizes considerably compared to when assuming an exponential distribution for OS.
Files in This Item:
T201803953.pdf Download
DOI
10.1016/j.conctc.2018.09.007
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Preventive Medicine and Public Health (예방의학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Biomedical Systems Informatics (의생명시스템정보학교실) > 1. Journal Papers
Yonsei Authors
Nam, Jung Mo(남정모) ORCID logo https://orcid.org/0000-0003-0985-0928
Rha, Sun Young(라선영) ORCID logo https://orcid.org/0000-0002-2512-4531
Jung, Inkyung(정인경) ORCID logo https://orcid.org/0000-0003-3780-3213
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/165407
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