Grant Number:	1R01CA088890-01A2 Interpret this number
Primary Investigator:	Lai, Tze
Organization:	Stanford University
Project Title:	Interim Analysis and Other Topics in Biostatistics
Fiscal Year:	2002

DESCRIPTION (provided by applicant): Because of the ethical and economic considerations in the design of clinical trials to test the efficacy and possible toxic effects of a newly developed drug or therapy, and because of the inherent sequential nature of the information flow during the course of the trial, there has been increasing interest from the biopharmaceutical industry in group sequential methods that can adapt to information acquired during the course of the trial and reduce the cost and study duration of conventional trials which assume a fixed sample size/study duration. An important objective of this research is to develop a comprehensive methodology for the design and analysis of group sequential trials. Certain long-standing problems in the field will be resolved in this connection, including valid confidence intervals following group sequential tests, calendar time versus information time in the case of failure-time endpoints, and sample size re-estimation during the course of a trial. A closely related objective is the development of nonlinear and nonparametric methods for the analysis of clinical trials with multiple endpoints, particularly those with combined efficacy-toxicity outcomes in cancer, arthritis and rheumatism treatments. Understanding the toxic-therapeutic relationships of these treatments will also help physicians to individualize and adapt the dose for different patients. Another objective of this research is to develop efficient statistical methods for nonlinear mixed effects models in population pharmacokinetics and for other problems in clinical pharmacology.




A new approach to regression analysis of censored competing-risks data.
Authors: Jin Y. , Lai T.L. .
Source: Lifetime Data Analysis, 2017 10; 23(4), p. 605-625.
EPub date: 2016-08-08 00:00:00.0.
PMID: 27502000
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Adaptive design of confirmatory trials: Advances and challenges.
Authors: Lai T.L. , Lavori P.W. , Tsang K.W. .
Source: Contemporary Clinical Trials, 2015 Nov; 45(Pt A), p. 93-102.
EPub date: 2015-06-14 00:00:00.0.
PMID: 26079372
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Innovative designs of point-of-care comparative effectiveness trials.
Authors: Shih M.C. , Turakhia M. , Lai T.L. .
Source: Contemporary Clinical Trials, 2015 Nov; 45(Pt A), p. 61-8.
EPub date: 2015-06-19 00:00:00.0.
PMID: 26099528
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Efficient Adaptive Designs With Mid-course Sample Size Adjustment In Clinical Trials
Authors: Bartroff,J. , Lai,T.L. .
Source: Statistics In Medicine, 2008-05-10 00:00:00.0; 27(10), p. 1593-611.
PMID: 18275090
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Stochastic Segmentation Models For Array-based Comparative Genomic Hybridization Data Analysis
Authors: Lai,T.L. , Xing,H. , Zhang,N. .
Source: Biostatistics (oxford, England), 2008 Apr; 9(2), p. 290-307.
PMID: 17855472
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Modified Haybittle-peto Group Sequential Designs For Testing Superiority And Non-inferiority Hypotheses In Clinical Trials
Authors: Lai,T.L. , Shih,M.C. , Zhu,G. .
Source: Statistics In Medicine, 2006-04-15 00:00:00.0; 25(7), p. 1149-67.
PMID: 16189814
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Flexible Modeling Via A Hybrid Estimation Scheme In Generalized Mixed Models For Longitudinal Data
Authors: Leung Lai,T. , Shih,M.C. , Wong,S.P. .
Source: Biometrics, 2006 Mar; 62(1), p. 159-67.
PMID: 16542242
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A New Approach To Modeling Covariate Effects And Individualization In Population Pharmacokinetics-pharmacodynamics
Authors: Lai,T.L. , Shih,M.C. , Wong,S.P. .
Source: Journal Of Pharmacokinetics And Pharmacodynamics, 2006 Feb; 33(1), p. 49-74.
PMID: 16402288
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