2005

BASS XII Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
M-1Kwan LeeBiomarker Discovery from High Dimensional Data
M-2Wayne AndersonThe Impact of Genomic Research on Drug Discovery and Development
M-3Xiaohong HuangBorrowing Information from Relevant Microarray Studies for Sample Classification Using Weighted Penalized Partial Least Squares
M-4Scott Chasalow Building Prognostic Models Using High-Dimensional SNP Data
M-5Russ WolfingerImproved Statistical Analysis of Data from Genetics, Microarrays, and Proteomics
M-6Tom BraunDetermining a Maximum-Tolerated Schedule of a Cytotoxic Agent
M-7Peter ThallSome Bayesian Methods for Clinical Trial Design and Analysis
Keynote AddressCarl PeckAdvances in Modeling and Simulation and the Impact on Drug Development and Regulation
T-1Ken WilkinsAllowing for Possibly Non-Ignorable Non-Response when Analyzing Longitudinal Outcomes in Clinical Trials: An Alternate Approach
T-2Daniel O. ScharfsteinA sensitive Analysis Paradigm for Randomized Trials with Missing or Censored Outcome Data
T-3Robert Goldberg-AlbertsTwo Methods for Analyzing Adverse Events
T-4David HuangBayesian Approach for the Design/Analysis of a Study for Handling a Rare Event Concept
T-5Frank Bretz and Jose Pinheiro Combining Multiple Comparisons and Modeling Techniques in Dose Response Studies
T-6Frank Harrell Statistical Graphics for Exploring Data Presenting Information, and Understanding Statistical Models
T-7Leonard Oppenheimer Learning More From Extension Studies
W-1David RossCurrent Development and Statistical Issues in the Office of Oncology
W-2Rajeshwari SridharaStatistical Challenges in Oncology Drug Development
W-3Mark RothmannOn Some Statistical Issues Involving Clinical Trials in Oncology

2004

BASS XI Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
M-1Kao-Tai TsaiCancer Research: Design, Analysis, and Recent Advances
M-2 Das D. PurkayasthaTopic 1: An Analysis of Expected Survival Differential in a Lung Cancer Trial: An Iterative Procedure with a Censored Regression Model
Topic 2: Determination of the Best Linear Unbiased Estimates (BLUES) of Incomplete Data for the Analysis of Repeated Measurements in Clinical Trials
M-3Qiming LiaoEnd Point in HIV Clinical Trials
M-4Qing LiuOptimizing Late Stage Clinical Development: A Cost-Effective Approach
M-5V. DevanarayanStatistical Consideration in Biomarker Method Development and Validation
M-6Gang Chen, Kevin Liu, George Chi and Yong-Cheng WangTopic 1: Margin Selection, Sample Size and Tests in the Design of Non-inferiority Trials
Topic 2: Statistical Method for Active Control Non-inferiority Trials with a Time to Event Endpoint
T-1Michael J. Brown and Robb J. MuirheadMultiple Primary Endpoints in Clinical Trials
T-2Keaven Anderson and Kevin LiuTopic 1: Comparison of Optimized Group Sequential and Adaptive Designs
Topic 2: Benefit-Risk Evaluation of Multi-stage Adaptive Designs
T-3Janet WittesMethods for Incorporating Flexibility in Clinical Trials
T-4William R. Meyers and William A. BrennemanUsing Robust Parameter Design in Industrial Experiments
Keynote AddressJanet WittesA Brief for Breaking our Rules
W-1Charles Anello, H .M. James Hung and Yi TsongFDA Session on Drug Development Issues: Critical Path, Clinical Trial Design, and Manufacturing and Quality Control

2003

BASS X Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
M-1Vern ChinchilliUnusual Clinical Trial Designs in the Asthma Clinical Research Network
M-2Karl PeaceUnusual and Interesting Applications from Three Decades of Biostatical Consulting
M-3John AndersenExpanding the Sphere of Influence of the Consulting Statistician
M-4Viswanathan RamakrishnanNormal Mixture Models for Gene Cluster Identification in Two Dimensional Microarray Data
M-5Gordon LanA Heuristic Approach to the Analysis of Survival Data
T-1Qing LiuPhase II/III Combination Design to Accelerate Drug Development
T-2Kathy Cronin and Ram TiwariNew Development in Population Based Survival
T-3Gary Koch and Catherine TangenNonparametric Analysis of Covariance and Its Role in Non-inferiority Clinical Trials
T-4Gary KochSome Statistical Strategies for Analyzing Confirmatory Studies Involving One or More Occurences of One or More Types of Primary Endpoints
Keynote AddressNancy GellerDilemmas In Monitoring Clinical Trials
W-1Robert Temple, Robert O'Neill, Susan Ellenberg and Karen MidthunJoint Special FDA CDER/CBER Session

2002

BASS IX Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
M-1Gordon LanOverruling of the Sequential Boundary and Sample Size Estimation
M-2Pat Darken and Matt SomervilleExamining Assumptions in the General Linear and Cox Regression Models: A Guide for the Pharmaceutical Industry Statistician
M-3Chen-Sheng Lin and Kalyanee Viraswami-AppannaA Comparison of Multiple Intensity Models with Cox Proportional Models and Annualized-Rate Method for Patients with Multiple Failure Outcomes
M-4Amy Ma and Akiko OkamatoAnalysis of Recurrent Events and Application to Clinical Trials
M-5Doug FariesImprovement in Clinical Trial Designs: Lead-Ins, Blinding and Rating Scales
T-1Christopher Schmid and Joseph CappelleriUsing Meta-Analysis to Explore Differences in Study Effects
T-2Robb Muirhead and Eve PickeringApplication of Multivariate Reference Regions to Clinical Laboratory Data
T-3R. K. ElswickSample Size and Power in the Mixed Model
T-4William DuMouchelDrug Adverse Event Surveillance Using the Multiple-Item Gamma Poisson Shrinker(MGPS)
Keynote AddressSusan EllenbergAssessing Risk: Old and New Challenges for the FDA
W-1Stan LinToward Better Clinical Designs Through Modern Simulation
W-2Rafia Bhore and Mohammad HuqueTime Dependence of Serious Adverse Events in the Assessment of Safety
W-3Raji Sridhara, George Chi and Robert O'NeillEvaluating Surrogate Endpoints Using Sensitivity and Specificity Analyses

11:00 AM

A Structured Approach to Designing Pivotal Diagnostic Accuracy Studies for Noninvasive Tests Using Meta-Analytic Techniques presented by Dr. Ryan Butterfield and Dr. Ed De Vol, Siemens