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Biomarker-Guided Trials
This chapter describes the field of precision or stratified medicine and the role that clinical trials play in the development and validation of...
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Biomarker-Guided Trials
This chapter describes the field of precision or stratified medicine and the role that clinical trials play in the development and validation of...
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Statistical Methods for Selective Biomarker Testing
Biomarkers are critically important tools in modern clinical diagnosis, prognosis, and classification/prediction. However, there are fiscal and...
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A three-stage approach to identify biomarker signatures for cancer genetic data with survival endpoints
The identification of prognostic and predictive biomarker signatures is crucial for drug development and providing personalized treatment to cancer...
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Estimating Dose and Time of Exposure from a Protein-Based Radiation Biomarker
In order to analyze the potential damage to the human body caused by exposure to ionizing radiation, one needs to have an estimation of the dose of...
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Optimal Biomarker Cutoff Identification and Validation
Advances in molecular technology have enabled the new drug development to shift toward targeted therapy where a subgroup of patients is more likely...
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Using Controlled Feeding Study for Biomarker Development in Regression Calibration for Disease Association Estimation
Correction for systematic measurement error in self-reported data is an important challenge in association studies of dietary intake and chronic...
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Biomarker-Driven Adaptive Phase III Clinical Trials
Developments in cancer genomics have dramatically changed oncology drug development. The discovery of important mutations in tumors has led to the...
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Biomarker-Targeted Confirmatory Trials
The design of confirmatory phase III trials involving predictive biomarkers has a wide range from enrichment design to all-comers design. The...
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Biomarker-Driven Adaptive Phase III Clinical Trials
Developments in cancer genomics have dramatically changed oncology drug development. The discovery of important mutations in tumors has led to the...
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Biomarker assessment in ROC curve analysis using the length of the curve as an index of diagnostic accuracy: the binormal model framework
In receiver operating characteristic (ROC) curve analysis, the area under the curve (AUC) is undoubtedly the most widely used index of diagnostic...
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Volume under the ROC surface for high-dimensional independent screening with ordinal competing risk outcomes
We propose a screening method for high-dimensional data with ordinal competing risk outcomes, which is time-dependent and model-free. Existing...
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Theory II: Estimation and Support Recovery
The regression model (1.1) in Sect. 1.1 relates blood levels of a biomarker with characteristics of the subjects’ genomes. Corresponding data allow...
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Non-parametric Frailty Model for the Natural History of Prostate Cancer; Using Data from a Screening Trial
Mixed-effects models for survival, known as frailty models, can be used to capture individual or cluster-specific unobserved heterogeneity. A common...
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Evaluating Dynamic Discrimination Performance of Risk Prediction Models for Survival Outcomes
Risk prediction models for survival outcomes are widely applied in medical research to predict future risk for the occurrence of the event. In many...
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Biomarker Assay Development, Qualification, and Validation
Biomarker is defined as a characteristic that is objectively measured and evaluated as an indicator of biological processes. A bioanalytical method...
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Characterize and Dichotomize a Continuous Biomarker
Dichotomization of continuous biomarkers is both clinically relevant and desirable since clinical decisions are usually based on categorization of...
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Adaptive Phase II Trials
Phase II trials are designed to obtain preliminary efficacy information about a new therapy in order to assess whether the new therapy should be...
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Innovative Designs for Biomarker-Guided Trials
Biomarkers are indispensable in the understanding of disease biology. It is believed that a validated biomarker with good predictive utility can...
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Biomarker Enrichment Design Considerations in Oncology Single Arm Studies
Oncology drug development has been increasingly shaped by molecularly targeted agents (MTAs), which often demonstrate differential effectiveness...