Abstract
The treatment of cancer has progressed dramatically in recent decades, such that it is no longer uncommon to see a cure or log-term survival in a significant proportion of patients with various types of cancer. To adequately account for the cure fraction when designing clinical trials, the cure models should be used. In this article, a sample size formula for the weighted log-rank test is derived under the fixed alternative hypothesis for the proportional hazards cure models. Simulation showed that the proposed sample size formula provides an accurate estimation of sample size for designing clinical trials under the proportional hazards cure models.
Original language | English |
---|---|
Pages (from-to) | 87-94 |
Number of pages | 8 |
Journal | Pharmaceutical Statistics |
Volume | 16 |
Issue number | 1 |
DOIs | |
State | Published - Jan 1 2017 |
Bibliographical note
Publisher Copyright:Copyright © 2016 John Wiley & Sons, Ltd.
Funding
This work was supported in part by National Cancer Institute support grant CA21765 and ALSAC.
Funders | Funder number |
---|---|
National Childhood Cancer Registry – National Cancer Institute | P30CA021765 |
American Lebanese Syrian Associated Charities |
Keywords
- clinical trial
- cure model
- log-rank test
- proportional hazards model
- sample size calculation
- survival analysis
ASJC Scopus subject areas
- Statistics and Probability
- Pharmacology
- Pharmacology (medical)