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Design and testing for clinical trials faced with misclassified causes of death

Bart Van Rompaye, Els Goetghebeur UGent and Shabbar Jaffar (2010) BIOSTATISTICS. 11(3). p.546-558
abstract
With clinical trials under pressure to produce more convincing results faster, we reexamine relative efficiencies for the semiparametric comparison of cause-specific rather than all-cause mortality events, observing that in many settings misclassification of cause of failure is not negligible. By incorporating known misclassification rates, we derive an adapted logrank test that optimizes power when the alternative treatment effect is confined to the cause-specific hazard. We derive sample size calculations for this test as well as for the corresponding all-cause mortality and naive cause-specific logrank test which ignores the misclassification. This may lead to new options at the design stage which we discuss. We reexamine a recently closed vaccine trial in this light and find the sample size needed for the new test to be 32% smaller than for the equivalent all-cause analysis, leading to a reduction of 41 224 participants.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
COMPETING RISKS, Misclassification, Sample size, Cause-specific analysis, Competing risks, Verbal autopsy, DISEASE, GAMBIA, END-POINTS, CHILDHOOD MORTALITY, MORTALITY FRACTIONS, VERBAL AUTOPSIES, MISSING FAILURE TYPE, UPPER RIVER DIVISION, Clinical trials, Survival analysis, PNEUMOCOCCAL CONJUGATE VACCINE
journal title
BIOSTATISTICS
Biostatistics
volume
11
issue
3
pages
546 - 558
Web of Science type
Article
Web of Science id
000278689300023
JCR category
STATISTICS & PROBABILITY
JCR impact factor
2.769 (2010)
JCR rank
4/110 (2010)
JCR quartile
1 (2010)
ISSN
1465-4644
DOI
10.1093/biostatistics/kxq011
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
1115048
handle
http://hdl.handle.net/1854/LU-1115048
date created
2011-02-02 14:02:22
date last changed
2016-12-19 15:45:26
@article{1115048,
  abstract     = {With clinical trials under pressure to produce more convincing results faster, we reexamine relative efficiencies for the semiparametric comparison of cause-specific rather than all-cause mortality events, observing that in many settings misclassification of cause of failure is not negligible. By incorporating known misclassification rates, we derive an adapted logrank test that optimizes power when the alternative treatment effect is confined to the cause-specific hazard. We derive sample size calculations for this test as well as for the corresponding all-cause mortality and naive cause-specific logrank test which ignores the misclassification. This may lead to new options at the design stage which we discuss. We reexamine a recently closed vaccine trial in this light and find the sample size needed for the new test to be 32\% smaller than for the equivalent all-cause analysis, leading to a reduction of 41 224 participants.},
  author       = {Van Rompaye, Bart and Goetghebeur, Els and Jaffar, Shabbar},
  issn         = {1465-4644},
  journal      = {BIOSTATISTICS},
  keyword      = {COMPETING RISKS,Misclassification,Sample size,Cause-specific analysis,Competing risks,Verbal autopsy,DISEASE,GAMBIA,END-POINTS,CHILDHOOD MORTALITY,MORTALITY FRACTIONS,VERBAL AUTOPSIES,MISSING FAILURE TYPE,UPPER RIVER DIVISION,Clinical trials,Survival analysis,PNEUMOCOCCAL CONJUGATE VACCINE},
  language     = {eng},
  number       = {3},
  pages        = {546--558},
  title        = {Design and testing for clinical trials faced with misclassified causes of death},
  url          = {http://dx.doi.org/10.1093/biostatistics/kxq011},
  volume       = {11},
  year         = {2010},
}

Chicago
Van Rompaye, Bart, Els Goetghebeur, and Shabbar Jaffar. 2010. “Design and Testing for Clinical Trials Faced with Misclassified Causes of Death.” Biostatistics 11 (3): 546–558.
APA
Van Rompaye, B., Goetghebeur, E., & Jaffar, S. (2010). Design and testing for clinical trials faced with misclassified causes of death. BIOSTATISTICS, 11(3), 546–558.
Vancouver
1.
Van Rompaye B, Goetghebeur E, Jaffar S. Design and testing for clinical trials faced with misclassified causes of death. BIOSTATISTICS. 2010;11(3):546–58.
MLA
Van Rompaye, Bart, Els Goetghebeur, and Shabbar Jaffar. “Design and Testing for Clinical Trials Faced with Misclassified Causes of Death.” BIOSTATISTICS 11.3 (2010): 546–558. Print.