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Grant Details

Grant Number: 5R01CA055098-06 Interpret this number
Primary Investigator: Lachine, John
Organization: George Washington University
Project Title: Statistical Methods for Cancer Clinical Trials
Fiscal Year: 1999


DESCRIPTION (Adapted from the applicant's abstract): The general objective of the proposed research is to develop sequential statistical methods for the data monitoring of complex clinical trials in cancer. In many of these clinical trials, the principal outcomes include immediate responses that can be completely measured soon after a patient enters the study; or in many others, time to an event, responses recorded periodically over time, or events that recur over time. Sequential monitoring of responses of these types usually fit into a unified framework. In a large clinical trial when data are monitored, a test statistic computed sequentially over time forms a stochastic process which is approximately Gaussian. In many practical situations, this process has independent increments and can be rescaled to become the Brownian motion process. The applicant proposes to investigate the monitoring of the Brownian motion process from different points of view. Each of the proposed research topics is directly motivated by current and anticipated statistical needs for the design and data monitoring of clinical trials. The three specific topics of research proposed are : (1) two-sample sequential comparisons of changes in repeated measures; (2) sequential analysis of Poisson data under a random effects model; and (3) occasional or continuous data monitoring in clinical trials. Additional research topics will be identified as work proceeds on these projects and in response to discussions with Dr. David DeMets of the University of Wisconsin Clinical Cancer Center and Dr. Timothy Chen of the National Cancer Institutes.


Over-ruling a group sequential boundary--a stopping rule versus a guideline.
Authors: Lan K.K. , Lachin J.M. , Bautista O. .
Source: Statistics in medicine, 2003-11-15; 22(21), p. 3347-55.
PMID: 14566919
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Application of robust estimating equations to the analysis of quantitative longitudinal data.
Authors: Hu M. , Lachin J.M. .
Source: Statistics in medicine, 2001-11-30; 20(22), p. 3411-28.
PMID: 11746326
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A flexible stochastic curtailing procedure for the log-rank test.
Authors: Bautista O.M. , Bain R.P. , Lachin J.M. .
Source: Controlled clinical trials, 2000 Oct; 21(5), p. 428-39.
PMID: 11018561
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Sequential monitoring of survival data with the Wilcoxon statistic.
Authors: Lan K.K. , Rosenberger W.F. , Lachin J.M. .
Source: Biometrics, 1995 Sep; 51(3), p. 1175-83.
PMID: 7548701
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Martingales without tears.
Authors: Lan K.K. , Lachin J.M. .
Source: Lifetime data analysis, 1995; 1(4), p. 361-75.
PMID: 9385110
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Use of surrogate information time for monitoring the effect of treatment on the change in a response variable in clinical trials.
Authors: Wu M.C. , Lan K.K. , Connett J.E. .
Source: Statistics in medicine, 1994-05-15; 13(9), p. 945-53.
PMID: 8047746
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Use of spending functions for occasional or continuous monitoring of data in clinical trials.
Authors: Lan K.K. , Rosenberger W.F. , Lachin J.M. .
Source: Statistics in medicine, 1993-12-15; 12(23), p. 2219-31.
PMID: 8310191
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Sequential monitoring of clinical trials: the role of information and Brownian motion.
Authors: Lan K.K. , Zucker D.M. .
Source: Statistics in medicine, 1993-04-30; 12(8), p. 753-65.
PMID: 8516592
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