"New Paradigms in Clinical Trial Methodology"
The symposium will consist of an interdisciplinary series of presentations centered around clinical trials and personalized medicine. Biostatisticians, clinical scientists, computational biologists and statistical geneticists will describe recent advances ranging from practical aspects to methodological developments in 6 scientific sessions covering the following topics:
- Biomarkers and Trial Design
- Adaptive Clinical Trial Design
- Design and Analysis Involving Complex Time-to-event Data
- Pharmacogenetic/Pharmacogenomic Analysis
- Assessment of Drug Safety
- Statistical Methods for Discovery of Individualized Treatment
This symposium will be of interest to clinical trial practitioners in industry and academia as well as others who have interest in recent and future directions in clinical trials and personalized medicine. We also hope the presentations and accompanying discussions will initiate future discoveries and progress in these important areas.
Agenda
8:30-8:40AM Welcome
8:40-9:35AM Session I: "Biomarkers and Trial Design"
Ed Korn, NCI, “Biomarker-adaptive clinical trial designs”
Xiaofei Wang, Duke, “Biased sampling and its applications in biomarker validation”
9:35-10:30AM Session II: "Pharmacogenetic/Pharmacogenomic Analysis"
Jung-Ying Tzeng, NC State, “A gene-trait similarity regression method for gene-level pharmacogenetics analysis”
Todd Auman, UNC, “Pharmacogenomic interrogation of colorectal cancer using next-generation whole exome sequencing”
10:30-10:45AM Break
10:45AM-12:30PM Session III: "Design and Analysis Involving Complex Time-to-event Data"
Jason Fine, UNC, “An overview of competing risks data, with applications in clinical trials”
Zhiguo Li, Duke, “Fitting Cox models with doubly censored data using spline-based marginal likelihood”
Donglin Zeng, UNC, “Estimating treatment effects with treatment switching via semi-competing risks models: An application to a colorectal cancer study”
Liddy Chen, UNC, “Design consideration for complex survival models”
12:30-1:40PM Lunch
1:40-2:35PM Session IV: "Adaptive Trial Design"
H.M. James Hung, FDA, “Utilities and challenges of adaptive designs in drug development”
Giovanni Parmigiani, Harvard, "Adaptive randomized trial design for patients with recurrent glioblastoma"
2:35-2:55PM Break
2:55-3:50PM Session V: "Assessment of Drug Safety"
Mark Levenson, FDA, “Safety decision-making with multiple sources and different types of studies—recent examples from FDA Advisory Committees”
David Madigan, Columbia, “Drug safety in spontaneous reports, observational databases, and clinical trials: Can we do better?”
3:50-4:10PM Break
4:10-5:30PM Session VI "Statistical Methods for Discovery of Individualized Treatment"
Marie Davidian, NC State, “A robust method for estimating optimal treatment regimes”
Yingqi Zhao, UNC, “Estimating Individualized Treatment Rules Using Outcome Weighted Learning”
Eric Laber, NC State, “Adaptive inference after model selection”
5:30PM Adjourn
Abstracts
Todd Auman, PHD Research Assistant Professor at UNC-Chapel Hill Institute for Pharmacogenomics and Individualized Therapy “Pharmacogenomic interrogation of colorectal cancer using next-generation whole exome sequencing”
Liddy Chen PHD Student, UNC-Chapel Hill Department of Biostatistics “Design consideration for complex survival models”
Marie Davidian, PHD William Neal Reynolds Professor in the Department of Statistics and Director of the Center for Quantitative Sciences in Biomedicine at NC State University “A robust method for estimating optimal treatment regimes”
Jason Fine, ScD Professor, UNC-Chapel Hill Department of Biostatistics “An overview of competing risks data, with applications in clinical trials”
H.M. James Hung, PHD Supervisory Mathematical Statistician and Director, Division of Biometrics I, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration (FDA) “Utilities and challenges of adaptive designs in drug development”
Edward Korn, PHD National Cancer Institute, Biometric Research Branch, Division of Cancer Treatment and Diagnosis “Biomarker-adaptive clinical trial designs”
Eric Laber, PHD Assistant Professor, NC State Department of Statistics “Adaptive inference after model selection”
Mark Levenson, PHD Supervisory Mathematical Statistician, Food and Drug Administration (FDA) “Safety decision-making with multiple sources and different types of studies—recent examples from FDA Advisory Committees”
Zhiguo Li, PHD Assistant Professor, Duke University Department of Biostatistics and Bioinformatics “Fitting Cox models with doubly censored data using spline-based marginal likelihood”
David Madigan, PHD Professor and Chair, Columbia University Department of Statistics “Drug safety in spontaneous reports, observational databases, and clinical trials: Can we do better?”
Giovanni Parmigiani, PHD Professor, Harvard University Department of Biostatistics "Adaptive randomized trial design for patients with recurrent glioblastoma"
Jung-Ying Tzeng, PHD Associate Professor, NC State Department of Statistics “A gene-trait similarity regression method for gene-level pharmacogenetics analysis”
Xiaofei Wang, PHD Assistant Professor, Duke University Department of Biostatistics and Bioinformatics “Biased sampling and its applications in biomarker validation”
Donglin Zeng, PHD Associate Professor, UNC-Chapel Hill Department of Biostatistics “Estimating treatment effects with treatment switching via semi-competing risks models: An application to a colorectal cancer study”
Yingqi Zhao PHD Student, UNC-Chapel Hill Department of Biostatistics “Estimating Individualized Treatment Rules Using Outcome Weighted Learning”