Grant Number:	5R01CA116723-03 Interpret this number
Primary Investigator:	Heitjan, Daniel
Organization:	University Of Pennsylvania
Project Title:	Statistical Methods in Smoking Cessation Research
Fiscal Year:	2009

DESCRIPTION (provided by applicant): Clinical research in smoking cessation has become an increasingly sophisticated enterprise. Although many of the design issues in smoking cessation research are similar to those encountered in other clinical areas, the types of outcomes measured and the structure of the outcome data have special features that set them apart. Standard methods of modeling and analysis that statisticians have developed over the years are therefore not well suited to handling data from smoking cessation trials. We propose to develop a range of statistical models and estimation procedures to handle the special features of smoking cessation outcomes. The availability of appropriate methods for this setting will further clinical research by permitting investigators to mine their data for new insights and design and analyze trials with maximum efficiency. This application describes a proposal by a team of experienced statisticians to address a range of critical methodologic problems arising in clinical trials of smoking cessation treatments. The first aim will investigate the problem of estimating the rates of smoking cure, together with the effects of treatments on cure and relapse rates, from data on cigarette consumption when subjects may experience alternating periods of abstinence and relapse. The second aim will consider models for daily cigarette consumption data in which the distribution of cigarette counts may exhibit excess zeros, a consequence of periods of abstinence; an integrated model based on smoking intensity rates will link models for abstinence and consumption given non-abstinence. The third aim will address the issue of heaping of cigarette counts - i.e., the tendency of subjects to report cigarette consumption rounded to the nearest multiple of five, ten or twenty cigarettes. The methods will be applied to data from a number of smoking cessation trials conducted by the University of Pennsylvania's NIH-funded Transdisciplinary Tobacco Use Research Center and the University of Pittsburgh, in which the three investigators have been active collaborators. It is anticipated, however, that the resulting methods will be applicable more broadly to clinical research on outcomes that experience alternating periods of relapse and remission.




Statistical justification of expansion cohorts in phase 1 cancer trials.
Authors: Mokdad A.A. , Xie X.J. , Zhu H. , Gerber D.E. , Heitjan D.F. .
Source: Cancer, 2018-07-05 00:00:00.0; , .
EPub date: 2018-07-05 00:00:00.0.
PMID: 29975406
Related Citations

Assessing the fit of parametric cure models.
Authors: Wileyto E.P. , Li Y. , Chen J. , Heitjan D.F. .
Source: Biostatistics (oxford, England), 2013 Apr; 14(2), p. 340-50.
PMID: 23197383
Related Citations

Sensitivity Of The Discrete-time Kaplan-meier Estimate To Nonignorable Censoring: Application In A Clinical Trial
Authors: Liu T. , Heitjan D.F. .
Source: Statistics In Medicine, 2012-11-10 00:00:00.0; 31(25), p. 2998-3010.
PMID: 22806989
Related Citations

Truth And Memory: Linking Instantaneous And Retrospective Self-reported Cigarette Consumption
Authors: Wang H. , Shiffman S. , Griffith S.D. , Heitjan D.F. .
Source: The Annals Of Applied Statistics, 2012; 6(4), p. 1689-1706.
PMID: 24432181
Related Citations

Prediction Of Individual Long-term Outcomes In Smoking Cessation Trials Using Frailty Models
Authors: Li Y. , Wileyto E.P. , Heitjan D.F. .
Source: Biometrics, 2011 Dec; 67(4), p. 1321-9.
PMID: 21401566
Related Citations

Statistical Analysis Of Daily Smoking Status In Smoking Cessation Clinical Trials
Authors: Li Y. , Wileyto E.P. , Heitjan D.F. .
Source: Addiction (abingdon, England), 2011 Nov; 106(11), p. 2039-46.
PMID: 21631623
Related Citations

Multiplicity-calibrated Bayesian Hypothesis Tests
Authors: Guo M. , Heitjan D.F. .
Source: Biostatistics (oxford, England), 2010 Jul; 11(3), p. 473-83.
PMID: 20212321
Related Citations

Modeling Smoking Cessation Data With Alternating States And A Cure Fraction Using Frailty Models
Authors: Li Y. , Wileyto E.P. , Heitjan D.F. .
Source: Statistics In Medicine, 2010-03-15 00:00:00.0; 29(6), p. 627-38.
PMID: 20077505
Related Citations

A Method Comparison Study Of Timeline Followback And Ecological Momentary Assessment Of Daily Cigarette Consumption
Authors: Griffith S.D. , Shiffman S. , Heitjan D.F. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2009 Nov; 11(11), p. 1368-73.
PMID: 19808861
Related Citations

Identification Of Pharmacogenetic Markers In Smoking Cessation Therapy
Authors: Heitjan D.F. , Guo M. , Ray R. , Wileyto E.P. , Epstein L.H. , Lerman C. .
Source: American Journal Of Medical Genetics. Part B, Neuropsychiatric Genetics : The Official Publication Of The International Society Of Psychiatric Genetics, 2008-09-05 00:00:00.0; 147B(6), p. 712-9.
PMID: 18165968
Related Citations

Modeling Heaping In Self-reported Cigarette Counts
Authors: Wang H. , Heitjan D.F. .
Source: Statistics In Medicine, 2008-08-30 00:00:00.0; 27(19), p. 3789-804.
PMID: 18407584
Related Citations