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Harvard University Biostatistics Working Paper Series

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Articles 1 - 19 of 19

Full-Text Articles in Clinical Trials

Studying The Optimal Scheduling For Controlling Prostate Cancer Under Intermittent Androgen Suppression, Sunil K. Dhar, Hans R. Chaudhry, Bruce G. Bukiet, Zhiming Ji, Nan Gao, Thomas W. Findley Jan 2017

Studying The Optimal Scheduling For Controlling Prostate Cancer Under Intermittent Androgen Suppression, Sunil K. Dhar, Hans R. Chaudhry, Bruce G. Bukiet, Zhiming Ji, Nan Gao, Thomas W. Findley

Harvard University Biostatistics Working Paper Series

This retrospective study shows that the majority of patients’ correlations between PSA and Testosterone during the on-treatment period is at least 0.90. Model-based duration calculations to control PSA levels during off-treatment are provided. There are two pairs of models. In one pair, the Generalized Linear Model and Mixed Model are both used to analyze the variability of PSA at the individual patient level by using the variable “Patient ID” as a repeated measure. In the second pair, Patient ID is not used as a repeated measure but additional baseline variables are included to analyze the variability of PSA.


The Myth Of Making Inferences For An Overall Treatment Efficacy With Data From Multiple Comparative Studies Via Meta-Analysis, Takahiro Hasegawa, Brian Claggett, Lu Tian, Scott D. Solomon, Marc A. Pfeffer, Lee-Jen Wei Jan 2016

The Myth Of Making Inferences For An Overall Treatment Efficacy With Data From Multiple Comparative Studies Via Meta-Analysis, Takahiro Hasegawa, Brian Claggett, Lu Tian, Scott D. Solomon, Marc A. Pfeffer, Lee-Jen Wei

Harvard University Biostatistics Working Paper Series

Meta analysis techniques, if applied appropriately, can provide a summary of the totality of evidence regarding an overall difference between a new treatment and a control group using data from multiple comparative clinical studies. The standard meta analysis procedures, however, may not give a meaningful between-group difference summary measure or identify a meaningful patient population of interest, especially when the fixed effect model assumption is not met. Moreover, a single between-group comparison measure without a reference value obtained from patients in the control arm would likely not be informative enough for clinical decision making. In this paper, we propose a …


Effectively Selecting A Target Population For A Future Comparative Study, Lihui Zhao, Lu Tian, Tianxi Cai, Brian Claggett, L. J. Wei Aug 2011

Effectively Selecting A Target Population For A Future Comparative Study, Lihui Zhao, Lu Tian, Tianxi Cai, Brian Claggett, L. J. Wei

Harvard University Biostatistics Working Paper Series

When comparing a new treatment with a control in a randomized clinical study, the treatment effect is generally assessed by evaluating a summary measure over a specific study population. The success of the trial heavily depends on the choice of such a population. In this paper, we show a systematic, effective way to identify a promising population, for which the new treatment is expected to have a desired benefit, using the data from a current study involving similar comparator treatments. Specifically, with the existing data we first create a parametric scoring system using multiple covariates to estimate subject-specific treatment differences. …


On The Covariate-Adjusted Estimation For An Overall Treatment Difference With Data From A Randomized Comparative Clinical Trial, Lu Tian, Tianxi Cai, Lihui Zhao, L. J. Wei Jul 2011

On The Covariate-Adjusted Estimation For An Overall Treatment Difference With Data From A Randomized Comparative Clinical Trial, Lu Tian, Tianxi Cai, Lihui Zhao, L. J. Wei

Harvard University Biostatistics Working Paper Series

No abstract provided.


Estimating Subject-Specific Treatment Differences For Risk-Benefit Assessment With Competing Risk Event-Time Data, Brian Claggett, Lihui Zhao, Lu Tian, Davide Castagno, L. J. Wei Mar 2011

Estimating Subject-Specific Treatment Differences For Risk-Benefit Assessment With Competing Risk Event-Time Data, Brian Claggett, Lihui Zhao, Lu Tian, Davide Castagno, L. J. Wei

Harvard University Biostatistics Working Paper Series

No abstract provided.


Stratifying Subjects For Treatment Selection With Censored Event Time Data From A Comparative Study, Lihui Zhao, Tianxi Cai, Lu Tian, Hajime Uno, Scott D. Solomon, L. J. Wei Sep 2010

Stratifying Subjects For Treatment Selection With Censored Event Time Data From A Comparative Study, Lihui Zhao, Tianxi Cai, Lu Tian, Hajime Uno, Scott D. Solomon, L. J. Wei

Harvard University Biostatistics Working Paper Series

No abstract provided.


Estimating Causal Effects In Trials Involving Multi-Treatment Arms Subject To Non-Compliance: A Bayesian Frame-Work, Qi Long, Roderick J. Little, Xihong Lin May 2010

Estimating Causal Effects In Trials Involving Multi-Treatment Arms Subject To Non-Compliance: A Bayesian Frame-Work, Qi Long, Roderick J. Little, Xihong Lin

Harvard University Biostatistics Working Paper Series

No abstract provided.


Nonparametric Regression With Missing Outcomes Using Weighted Kernel Estimating Equations, Lu Wang, Andrea Rotnitzky, Xihong Lin Apr 2010

Nonparametric Regression With Missing Outcomes Using Weighted Kernel Estimating Equations, Lu Wang, Andrea Rotnitzky, Xihong Lin

Harvard University Biostatistics Working Paper Series

No abstract provided.


Utilizing The Integrated Difference Of Two Survival Functions To Quantify The Treatment Contrast For Designing, Monitoring And Analyzing A Comparative Clinical Study, Lihui Zhao, Lu Tian, Hajime Uno, Scott D. Solomon, Marc A. Pfeffer, J. S. Schindler, L. J. Wei Apr 2010

Utilizing The Integrated Difference Of Two Survival Functions To Quantify The Treatment Contrast For Designing, Monitoring And Analyzing A Comparative Clinical Study, Lihui Zhao, Lu Tian, Hajime Uno, Scott D. Solomon, Marc A. Pfeffer, J. S. Schindler, L. J. Wei

Harvard University Biostatistics Working Paper Series

No abstract provided.


Graphical Procedures For Evaluating Overall And Subject-Specific Incremental Values From New Predictors With Censored Event Time Data, Hajime Uno, Tianxi Cai, Lu Tian, L. J. Wei Mar 2010

Graphical Procedures For Evaluating Overall And Subject-Specific Incremental Values From New Predictors With Censored Event Time Data, Hajime Uno, Tianxi Cai, Lu Tian, L. J. Wei

Harvard University Biostatistics Working Paper Series

No abstract provided.


A Comparison Of Methods For Estimating The Causal Effect Of A Treatment In Randomized Clinical Trials Subject To Noncompliance, Rod Little, Qi Long, Xihong Lin Jun 2008

A Comparison Of Methods For Estimating The Causal Effect Of A Treatment In Randomized Clinical Trials Subject To Noncompliance, Rod Little, Qi Long, Xihong Lin

Harvard University Biostatistics Working Paper Series

No abstract provided.


Nonparametric Inference Procedure For Percentiles Of The Random Effect Distribution In Meta Analysis, Rui Wang, Lu Tian, Tianxi Cai, L. J. Wei Apr 2008

Nonparametric Inference Procedure For Percentiles Of The Random Effect Distribution In Meta Analysis, Rui Wang, Lu Tian, Tianxi Cai, L. J. Wei

Harvard University Biostatistics Working Paper Series

No abstract provided.


Estimation Of Controlled Direct Effects, Sylvie Goetgeluk, Stijn Vansteelandt, Els Goetghebeur Jan 2008

Estimation Of Controlled Direct Effects, Sylvie Goetgeluk, Stijn Vansteelandt, Els Goetghebeur

Harvard University Biostatistics Working Paper Series

No abstract provided.


Correcting Instrumental Variables Estimators For Systematic Measurement Error, Stijn Vansteelandt, Manoochehr Babanezhad, Els Goetghebeur Aug 2007

Correcting Instrumental Variables Estimators For Systematic Measurement Error, Stijn Vansteelandt, Manoochehr Babanezhad, Els Goetghebeur

Harvard University Biostatistics Working Paper Series

No abstract provided.


Effectively Combining Independent 2 X 2 Tables For Valid Inferences In Meta Analysis With All Available Data But No Artificial Continuity Corrections For Studies With Zero Events And Its Application To The Analysis Of Rosiglitazone's Cardiovascular Disease Related Event Data, Lu Tian, Tianxi Cai, Nikita Piankov, Pierre-Yves Cremieux, L. J. Wei Aug 2007

Effectively Combining Independent 2 X 2 Tables For Valid Inferences In Meta Analysis With All Available Data But No Artificial Continuity Corrections For Studies With Zero Events And Its Application To The Analysis Of Rosiglitazone's Cardiovascular Disease Related Event Data, Lu Tian, Tianxi Cai, Nikita Piankov, Pierre-Yves Cremieux, L. J. Wei

Harvard University Biostatistics Working Paper Series

No abstract provided.


Identifying Patients Who Need Additional Biomarkers For Better Prediction Of Health Outcome Or Diagnosis Of Clinical Phenotype, Lu Tian, Tianxi Cai, L. J. Wei Jun 2007

Identifying Patients Who Need Additional Biomarkers For Better Prediction Of Health Outcome Or Diagnosis Of Clinical Phenotype, Lu Tian, Tianxi Cai, L. J. Wei

Harvard University Biostatistics Working Paper Series

No abstract provided.


Designed Extension Of Survival Studies: Application To Clinical Trials With Unrecognized Heterogeneity, Yi Li, Mei-Chiung Shih, Rebecca A. Betensky Oct 2005

Designed Extension Of Survival Studies: Application To Clinical Trials With Unrecognized Heterogeneity, Yi Li, Mei-Chiung Shih, Rebecca A. Betensky

Harvard University Biostatistics Working Paper Series

It is well known that unrecognized heterogeneity among patients, such as is conferred by genetic subtype, can undermine the power of randomized trial, designed under the assumption of homogeneity, to detect a truly beneficial treatment. We consider the conditional power approach to allow for recovery of power under unexplained heterogeneity. While Proschan and Hunsberger (1995) confined the application of conditional power design to normally distributed observations, we consider more general and difficult settings in which the data are in the framework of continuous time and are subject to censoring. In particular, we derive a procedure appropriate for the analysis of …


The Optimal Confidence Region For A Random Parameter, Hajime Uno, Lu Tian, L.J. Wei Jul 2004

The Optimal Confidence Region For A Random Parameter, Hajime Uno, Lu Tian, L.J. Wei

Harvard University Biostatistics Working Paper Series

Under a two-level hierarchical model, suppose that the distribution of the random parameter is known or can be estimated well. Data are generated via a fixed, but unobservable realization of this parameter. In this paper, we derive the smallest confidence region of the random parameter under a joint Bayesian/frequentist paradigm. On average this optimal region can be much smaller than the corresponding Bayesian highest posterior density region. The new estimation procedure is appealing when one deals with data generated under a highly parallel structure, for example, data from a trial with a large number of clinical centers involved or genome-wide …


A Nonparametric Comparison Of Conditional Distributions With Nonnegligible Cure Fractions, Yi Li, Jin Feng Nov 2003

A Nonparametric Comparison Of Conditional Distributions With Nonnegligible Cure Fractions, Yi Li, Jin Feng

Harvard University Biostatistics Working Paper Series

No abstract provided.