Tutorials

BASS XXII Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Richardus Vonk	Bayesian Applications in Biomarker Detection
M-2	Jeff Palmer	Monitoring Accrual and Events in a Time-to-Event Endpoint Trial
M-3	Kao-Tai Tsai	Analysis of Response Profiles of Clinical Trial Data
M-4	Cong Chen	Informational Desigs of Phase III Trials for Expedited Development of Cancer Immuno-oncology Therapies with a Putative Predictive Biomarker
M-5	Gordon Lan	Design of Multiregional Clinical Trials (MRCT)–Theory and Practice
M-6	Macaulay Okwuokenye	Discrete Time-to-event and Score-based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity-Free
M-7	Steven Gilbert	Applied Missing Data: Causal Estimands and Clinicians
M-8	Neal Thomas	Clinical Trials with Incomplete Daily Diary Data
T-1	Shankar Srinivasan	Missing Data, Imputation and Variable Selection in Multivariate Modeling
T-2	Ben Trzaskoma	Optimality when Analyzing Cross-Over Designs without Wash-out Periods
T-3	Ibrahim Turkoz	A Bayesian Analysis of Disease Modification using Doubly Randomized Delay-Start and Matched-Control Design Paradigms
T-4	Irene Hueter	When Local Virus Outbreaks Become a Global Health Concern – How to Detect Them Earlier Than Witnessed for Ebola in 2014
T-5	Robin Mogg	Simulation-based Trial Design to Inform an Innovative and Adaptive Statistical Strategy
T-6	Bart Spiessens	Statistical Design Challenges of a Phase 2/3 Randomized Placebo-controlled Ebola Vaccine Trial
T-7	Deb Zarin	Everything You Always Wanted to Know About ClinicalTrials.gov
T-8	Bryan Luce	The Pragmatic Clinical Trial Meets the Learning Healthcare System
Keynote Address	Steven Anderson	Regulatory Science: Innovations in Assessing Effectiveness, Safety and Benefit-Risk for Biologics
W-1	Mo Huque & Sirisha Mushti	Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials

BASS XXI Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Inna Perevozskaya	Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines
M-2	Vlad Dragalin	Complex Adaptive Designs in Drug Development
M-3	Kyle Wathen	Utilizing Prediction and Simulation to Guide Clinical Trial Design
M-4	Stephanie Green	Optimizing Phase 1 and 2 Clinical Trials Design
M-5	Vivian Shih and Paul Gallo	Viewpoints on Setting Clinical Trial Futility Criteria
M-6	Bob Noble	Phase 2B Design Considerations Assessing Dose Response Modeling
M-7	Changlu Liu	A Decision-Theoretic Bayes Factor Approach for Dose Finding in Phase I Oncology Trials
M-8	Frank Rockhold	Access to Anonymised Patient Level Data: Experiences from GSK
Keynote Address	ShaAvhree Buckman-Garner	Leveraging Innovation and Change through Regulatory Science Initiatives
T-1	Joe Cappelleri	Interpretation of Patient-Reported Outcomes
T-2	Jesse Berlin	Harnessing Next-Generation Informatics for Personalizing Medicine: Personalization of Care and Research
T-3	Kevin Gan	An Extended Longitudinal Model and Graphic for Benefit Risk Analysis
T-4	Richard Simon	An Overview of Adaptive Biomarker-driven Clinical Trial Designs
T-5	Lisa McShane	Assessment of Omics-based Predictor Readiness for Use in a Clinical Trial
T-6	Edward Korn	Design of Phase II Clinical Trials with a Potential Predictive Biomarker
T-7	Boris Freidlin	Phase III Design Considerations for Molecularly Targeted Agents
T-8	Lisa LaVange, Lisa McShane, Dionne Price, Rajeshwari Sridhara, Shenghui Tang	Master Protocols and their Role in Drug Development
W-1	Mohammad Huque and Kathleen Fritsch	Multiplicity Problems in Clinical Trials – A Regulatory Perspective

BASS XX Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Steve Ruberg	Post-Marketing Safety Assessments The Journey
M-2	Amy Xia and Qi Jiang	Statistical Evaluation of Drug Safety Data
M-3	Brian Smith	Early Safety Signal Detection
M-4	Viswanath Devanarayan	Discovery & Development of Biomarker Candidates for Drug Development
M-5	Roy Sabo	The Use of Decreasingly Informative Priors in Adaptive Clinical Trial Designs
M-6	Ibrahim Turkoz	Blinded Evaluations of Effect Sizes in Clinical Trials: Comparisons Between Bayesian and EM Analyses
M-7	Neal Thomas	Meta-Analysis of Clinical Dose Response in a Large Drug Development Portfolio
T-1	Melissa Spann	Looking for Clinical Activity in a First-in-Human Study
T-2	Feng Liu	Between-Endpoint Predictive Model to Support Phase III Clinical Design
T-3	Shanhong Guan	Optimal Statistical Design for Phase I Cancer Clinical Trials: A Simulaton Study
T-4	Knut M. Wittkowski	U-Statistics for Multiple Censored Outcomes with Varying Frequency, Severity, Attribution
T-5	Michael Durante	The Role of Statistical Graphics in Oncology Drug Development-Moving Beyond Scatter Plots and Survival Curves
T-6	Qing Liu	Understanding the FDA Guidance on Adaptive Designs: Historical, Legal, and Statistical Perspectives
Keynote Address	Michael Proschan	FDA Advisory Committees: Message to the Pharmaceutical Industry and Academia
W-1	Brian Millen	Decision Making in Confirmatory Multipopulation Tailoring Trials
W-2	Fangyi Zhao	Pomaglumetad Methionil: A Case Study in Incremental Learning throughout Clinical Development
W-3	Mohamed Alosh	Subgroup Supportive Evidence for Consistency with the Overall Population Efficacy
W-4	Gene Pennello	Bayesian Hierarchical Models for Subgroup Analysis of Clinical Studies

BASS XIX Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Russell Reeve	Model-Based Drug Development
M-2	Jeffrey Morris	Modeling High-Dimension Functioning and Image Data
M-3	Ying Yuan	Bayesian Optimal Interval Design for Phase I Clinical Trial
M-4	Roy Sabo	A Bayesian Adaptive Allocation Method for Clinical Trial and Dual Objectives
M-5	Cory Heilmann	Use of Bayesian Evidence Synthesis Techniques Across Phases of Drug Development
M-6	Doug Faries	Comparative Effectiveness Analysis from Observational Data
M-7	Joe Cappelleri	Network Meta-Analysis for Comparative Effectiveness Research
M-8	Susan Duke	Graphs are Statistical Methods Too! The Case for Graphics in Safety and Benefit-Risk Analysis
Keynote Address	Christy Chuang-Stein	Career in Pharmaceutical Industry: Exciting, Challenging and Rewarding
T-1	Melvin Munsaka	Statistical Analysis of Safety Data – A Survey of Some Analysis Methods
T-2	Frank Rockhold	Enhancing the Way We Quantify and Communicate Benefit to Risk in the Pre and Post Approval Arena
T-3	Jesse Berlin	Opportunities and Challenges for Using Networks of Observational Healthcare Data for Medical Product Safety Surveillance
T-4	Zhenzhen Xu	Propensity Scoring Matching in Cluster Randomized Trials
T-5	Xiaolong Luo	A Multiple Comparison Procedure for Hypotheses with Gatekeeping Structures
T-6	Colleen Twomey	21st Century Drug Development: The Road to Consistency and Transparency
W-1	Aloka Chakravarty	Quantitative Safety Evaluation at CDER
W-2	Estelle Russek-Cohen	Safety Throughout the Life Cycle of Vaccines
W-3	Mark Levenson	Quantitative Safety Assessment During the Post-Marketing Phase: Examples at FDA/CDER
W-4	Christy Chuang-Stein	Safety Assessment of Pharmaceutical Products

BASS XVIII Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Inna Perevozskaya	Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines
M-2	Vlad Dragalin	Complex Adaptive Designs in Drug Development
M-3	Kyle Wathen	Utilizing Prediction and Simulation to Guide Clinical Trial Design
M-4	Stephanie Green	Optimizing Phase 1 and 2 Clinical Trials Design
M-5	Vivian Shih and Paul Gallo	Viewpoints on Setting Clinical Trial Futility Criteria
M-6	Bob Noble	Phase 2B Design Considerations Assessing Dose Response Modeling
M-7	Changlu Liu	A Decision-Theoretic Bayes Factor Approach for Dose Finding in Phase I Oncology Trials
M-8	Frank Rockhold	Access to Anonymised Patient Level Data: Experiences from GSK
Keynote Address	ShaAvhree Buckman-Garner	Leveraging Innovation and Change through Regulatory Science Initiatives
T-1	Joe Cappelleri	Interpretation of Patient-Reported Outcomes
T-2	Jesse Berlin	Harnessing Next-Generation Informatics for Personalizing Medicine: Personalization of Care and Research
T-3	Kevin Gan	An Extended Longitudinal Model and Graphic for Benefit Risk Analysis
T-4	Richard Simon	An Overview of Adaptive Biomarker-driven Clinical Trial Designs
T-5	Lisa McShane	Assessment of Omics-based Predictor Readiness for Use in a Clinical Trial
T-6	Edward Korn	Design of Phase II Clinical Trials with a Potential Predictive Biomarker
T-7	Boris Freidlin	Phase III Design Considerations for Molecularly Targeted Agents
T-8	Lisa LaVange, Lisa McShane, Dionne Price, Rajeshwari Sridhara, Shenghui Tang	Master Protocols and their Role in Drug Development
W-1	Mohammad Huque and Kathleen Fritsch	Multiplicity Problems in Clinical Trials – A Regulatory Perspective

BASS XVII Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Xiaolong Luo and Peter S. Ouyang	A Process View of Statistics for Clinical Trials: ANOVA, Product-Limit and Adaptive Design
M-2	Qing Liu, Pilar Lim, Barry Schwab and Jaskaran Singh	Adaptive Doubly-Randomized Delayed-Start Design and Applications to Anti-Depressant Drug Development
M-3	Alex Sverdlov	Covariate-Adjusted Response-Adaptive Randomization Designs for Phase III Survival Trials
M-4	Shanhong Guan	Sample Size Re-estimation in a Two-stage Design Using p-Value Combination Tests
M-5	Tom Stiger	Failure-time Mixture Models for Analyzing Time to Response
M-6	Jihong Chen and Jane Qian	Enrollment and Endpoint Projection in Oncology Clinical Trials
M-7	Yoko Tanaka	Statistical Considerations in Multi-Regional Clinical Trials
Keynote Address	Mohammad Huque	Multiplicity Problems in Controlled Clinical Trials: Regulatory Perspective
T-1	Adam Hamm	Implementing the Continous Reassessment Method (CRM) in a Phase I Oncology Trial
T-2	Laszlo Endrenyi	Scaled Average Bioequivalence: An Approach to Resolve a Difficult Problem
T-3	George Y. H. Chi and Gang Li	A New Development and Perspective on the Design, Analysis & Interpretation of Non-inferiority Trials
T-4	David Nelson and Carlos Alatorre	Methodological Considerations in Comparative Effectiveness Research
T-5	Mark Reimers	Estimation Issues in High-throughput Data Analysis
W-1	Par Karlsson	Multiple Testing in a Partitioning Framework
W-2	Mohamed Alosh	Recent Developments in Addressing Multiplicity Issues in Clinical Trials
W-3	Mohammad Huque	Decomposition of a Composite Endpoint for Assessing Treatment Benefits for its Components

BASS XVI Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Yuan Ji	Dose Finding in Oncology Clinical Trials Based on Unit Probability Mass
M-2	Alex Sverdlov	Implementing Response-Adaptive Randomization in Multi-Armed Survival Trial
M-3	Martin King	Evaluating Probability of Success in Oncology Clinical Trial
M-4	Matthew Somerville	Design and Analysis of a Cancer Prevention Trial: Plans and Results
M-5	Greg Cicconetti	Comparing Conditional and Predictive Power to Assess Futility in a Phase III Program with Two Studies
M-6	Rebecca Brown	Setting Alpha Levels for Testing Key Secondary Endpoints in Trials with Interim Assessments When the Primary and Secondary Endpoints Are Correlated
M-7	Nitai D. Mukhopadhyay	Efficient Sampling of Inverse Correlation Matrices and its Applications with Baysian Modelling of Gene Interaction in Early Phase Genomic Experiment
Keynote Address	Shein-Chung Chow	Controversial Issues in Clinical Trials
T-1	Stephen J. Ruberg	The Mean Ain't What It Used To Be
T-2	Karl E. Peace	Subgroup Data Analysis of Clinical Trials-Issues and Methods
T-3	Larry Leon	Analysis of Aid Dose Selection in Phase 2 Virology Clinical Trials
T-4	Michael O'Connell	Statistical Graphics for Exploratory Review and Reporting in Clinical Trials
T-5	Cristiana Gassmann-Mayer	Statistical Assessment and Analyses of Suicidality Data in Clinical Trials
T-6	David Manner	Using Statistical Principles to Implement FDA Guidance on Cardiovascular Risk Assessment for Diabetes Drugs
W-1	George Rochester	Safety Planning Throughout the Product Life-cycle
W-2	Antonio Paredes	On Methodologies Associated with Met-analysis
W-3	Mark Van der Laan	Target Maximum Likelihood Super Learning : Application to Causal Effects in Safety Analysis

BASS XV Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Susan Parker and Lixin Lang	Phase I Oncology Designs: Comparisons and Extensions
M-2	Zixing Fang	Analyzing Phase 2 Proof-of-Concept Clinical Trials with Baseline and Post-Treatment Measurements
M-3	Yuan Ji	Bayesian Adaptive Designs for Early Phase Clinical Trials
M-4	Shumei S. Sun	A Double Blind, Two-Arm Placebo Controlled Trial of Alendronate in Patients with Gaucher's Disease
M-5	Yin Yin	Qualification in the Internal Decision Making Process
M-6	Andreas Sashegyi	Application of Learning Maps in Pharmaceutical Research and Development
M-7	Patrick Peterson	PISC Expert Team White Paper: Toward a Consistent Standard of Evidence when Evaluating the Efficacy of an Experiment Treatment from a Randomized, Active-controlled Trial
Keynote Address	Donald A. Berry	New Developments in Bayesian Clinical Trials
T-1	David Raunig	Imaging Basics
T-2	Yonghua Wang	Statistical Considerations of Using Medicine Imaging Techniques in Clinical Trials
T-3	Takashi Sozu	Power and Sample Size Calculations in Clinical Trials with Multiple Co-primary Endpoints
T-4	Yonghua Wang	Effective Use of Data in Incomplete Crossover Designs: Theory and Application
T-5	Iiya Lipkovich	Identification of Promising Subgroups in the Retrospective Analysis of Clinical Trials
T-6	Ramses Sadek	Patient Reported Outcome/Quality of Life Assessment in Clinical Trials
W-1	Jerald Schindler	Adaptive Trials: Unlocking the Opportunity and the Competitive Advantage
W-2	Steven Bai	Sample Size Re-estimation
W-3	George Kordzakhia	Bonferroni-Based Tree-Structured Gatekeeping Testing Procedures

BASS XIV Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Mike Davenport	An Adaptive Dose Finding Design (DOSEFIND): Using a Nonlinear Dose Response Model
M-2	Susan Willavize	Dose Response Modeling for Combination Drug Products
M-3	Neal Thomas	Bayesian Analysis of Dose Response
M-4	Jason Liao	Concordance Analysis in the Biopharmaceutical Industry
M-5	Yongming Qu	Surrogate Markers Validation: What should be Considered?
M-6	Craig Trost	An Introduction to Pathodynamics from the View of Liver Homeostatis Using the Ornstein-Uhlenbeck Process
M-7	Jonathan S. Schildcrout	Analyses of Longitudinal Clinical Lab Data with Latent Mixture Models
M-8	Michael O'Connell	Statistical Modeling and Graphical Analysis of Safety Data in Clinical Trials
Keynote Address	Mitchell Gail	Absolute Risk: Clinical Application and Contoversies
T-1	Vlad Dragalin	Adaptive Modeling-based Designs in Clinical Drug Development
T-2	Quan Hong	A New Method for Steady State Assessment Based on Nonlinear Mixed Effect Modeling
T-3	Cancelled	Cancelled
T-4	Robb Muirhead	Moving Beyond QT in Assessing the Arrhythmic Liability of Drugs
T-5	Anthony Segreti	Strategies for Meta-Analyses of Randomized Controlled Trials Based on Individual Patient Data
T-6	Edit Kurali	Statistical Issues in Predictive Toxicology
W-1	Guoxing Soon	Handling Missing Data in Clinical Trials -Design and Analysis Issues with Examples from the Anti-viral Area
W-2	Mohamed Alosh	Analysis of Longitudinal Count Data with Possibility of Dropouts
W-3	Thamba Valappil	An Overview of Causal Inference and its Applications in Clinical Trials
W-4	Adam Meyers	Developing an Analytic Road Map for Incomplete Longitudinal Clinical Trial

BASS XIII Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
Keynote Address	Greg Campbell	The World of Medical Devices and Its Increasing Impact on Pharmaceutical Statistics
M-1	Stephan Ogenstad	Simulation for Designing and Analyzing Clinical Trials
M-2	Dejun Tang	Comparison of Statistical Analysis Methods Using Modeling and Simulations in Modern Protocol Design
M-3	Naitee Ting	Dose Finding in Drug Development : Study Design Considerations
M-4	Mark J. Van der Laan	Resampling Based Multiple Testing: Controlling Proportion of False Positives
M-5	Michael O'Connell	Standardized Graphics for Safety Using S-Plus Software
M-6	Ralph Raymond and Frank Shen	Model Based Adaptive Design
M-7	Tim Montague	Bioequivalence Trials Designed Using Adaptive Methodologies
T-1	Rong Liu	A comparison of Methods for Longitudinal Data Missing due to Truncation
T-2	Julia Wang and Akiko Okamoto	Rescue Behavior and Imputation Strategies in Analgesic Studies
T-3	Robert E. Johnson and Heather J. Hoffman	Multivariate Assays with Values Below the Lower Limit of Quantitation: Parametric Estimation by Imputation and Maximum Likelihood
T-4	Andrew Strahs	Variability in Gene Expression in Healthy Volunteers
T-5	Shein-Chung Chow	Adaptive Design Methods in Clinical Trials
W-1	Mohammad Huque	On Some Statistical Considerations in Planning and Testing of Multiple Endpoints in Clinical Trials
W-2	Gouxing (Greg) Soon	Issues and Considerations for Composite Endpoints Use in Clinical Trials
W-3	Atiar Rahman	Recent Results Concerning Multiplicities in Animal Carcinogenicity Studies
W-4	Alex Dmitrienko	Tree-structured Gatekeeping Procedures in Clinical Trials with Multiple Objectives