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Grant Details

Grant Number: 5R01CA052733-07 Interpret this number
Primary Investigator: Kim, Kyungmann
Organization: University Of Wisconsin Madison
Project Title: Sequential Methods for Clinical Trials
Fiscal Year: 1998


Abstract

DESCRIPTION: The investigator proposes to extend group sequential methods for early stopping of clinical trials and epidemiologic studies. The specific aims of the proposal are: 1) to develop group-sequential methods for clinical trials in which some portion of the patients are considered cured of the disease, 2) to develop group-sequential methods for clinical trials with repeated measures, e.g., longitudinal studies, potentially with missing data, 3) to develop group-sequential methods for epidemiologic studies such as retrospective case-control studies and prospective cohort studies, and 4) to develop "work-arounds" to the problem of 'overrunning' and 'underrunning' the maximum information in long-term clinical trials. Development of practical guidelines for implementation of the proposed methods will be emphasized, and data from clinical trials will be utilized in investigating the practical aspects of the proposed methods. The group sequential methods rely primarily on a design paradigm using the Lan-DeMets (1983) type I error spending function approach, which can be implemented in a standard way when an 'independent increments' structure of sequentially computed test statistics is established.



Publications

A Novel Means Of Using Gene Clusters In A Two-step Empirical Bayes Method For Predicting Classes Of Samples
Authors: Ji Y. , Tsui K.W. , Kim K. .
Source: Bioinformatics (oxford, England), 2005-04-01 00:00:00.0; 21(7), p. 1055-61.
PMID: 15514000
Related Citations

On The Estimation Of The Binomial Probability In Multistage Clinical Trials
Authors: Jung S.H. , Kim K.M. .
Source: Statistics In Medicine, 2004-03-30 00:00:00.0; 23(6), p. 881-96.
PMID: 15027078
Related Citations

Admissible Two-stage Designs For Phase Ii Cancer Clinical Trials
Authors: Jung S.H. , Lee T. , Kim K. , George S.L. .
Source: Statistics In Medicine, 2004-02-28 00:00:00.0; 23(4), p. 561-9.
PMID: 14755389
Related Citations

Group Sequential Methods For An Ordinal Logistic Random-effects Model Under Misspecification
Authors: Spiessens B. , Lesaffre E. , Verbeke G. , Kim K. .
Source: Biometrics, 2002 Sep; 58(3), p. 569-75.
PMID: 12229991
Related Citations

Graphical Search For Two-stage Designs For Phase Ii Clinical Trials
Authors: Jung S.H. , Carey M. , Kim K.M. .
Source: Controlled Clinical Trials, 2001 Aug; 22(4), p. 367-72.
PMID: 11514038
Related Citations

Design And Analysis Of Group Sequential Logrank Tests In Maximum Duration Versus Information Trials
Authors: Kim K. , Boucher H. , Tsiatis A.A. .
Source: Biometrics, 1995 Sep; 51(3), p. 988-1000.
PMID: 7548714
Related Citations

Seqpwr And Seqopr: Computer Programs For Design Of Maximum Information Trials Based On Group Sequential Logrank Tests
Authors: Kim K. .
Source: Computer Methods And Programs In Biomedicine, 1995 Feb; 46(2), p. 143-53.
PMID: 7796583
Related Citations

Study Duration For Group Sequential Clinical Trials With Censored Survival Data Adjusting For Stratification
Authors: Kim K. .
Source: Statistics In Medicine, 1992 Aug; 11(11), p. 1477-88.
PMID: 1329172
Related Citations

Sample Size Determination For Group Sequential Clinical Trials With Immediate Response
Authors: Kim K. , Demets D.L. .
Source: Statistics In Medicine, 1992 Jul; 11(10), p. 1391-9.
PMID: 1518999
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