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

2001

BASS VIII Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
M-1Richardus VonkBayesian Applications in Biomarker Detection
M-2Jeff PalmerMonitoring Accrual and Events in a Time-to-Event Endpoint Trial
M-3Kao-Tai TsaiAnalysis of Response Profiles of Clinical Trial Data
M-4Cong ChenInformational Desigs of Phase III Trials for Expedited Development of Cancer Immuno-oncology Therapies with a Putative Predictive Biomarker
M-5Gordon LanDesign of Multiregional Clinical Trials (MRCT)–Theory and Practice
M-6Macaulay OkwuokenyeDiscrete Time-to-event and Score-based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity-Free
M-7Steven GilbertApplied Missing Data: Causal Estimands and Clinicians
M-8Neal ThomasClinical Trials with Incomplete Daily Diary Data
T-1Shankar SrinivasanMissing Data, Imputation and Variable Selection in Multivariate Modeling
T-2Ben TrzaskomaOptimality when Analyzing Cross-Over Designs without Wash-out Periods
T-3Ibrahim TurkozA Bayesian Analysis of Disease Modification using Doubly Randomized Delay-Start and Matched-Control Design Paradigms
T-4Irene HueterWhen Local Virus Outbreaks Become a Global Health Concern – How to Detect Them Earlier Than Witnessed for Ebola in 2014
T-5Robin MoggSimulation-based Trial Design to Inform an Innovative and Adaptive Statistical Strategy
T-6Bart SpiessensStatistical Design Challenges of a Phase 2/3 Randomized Placebo-controlled Ebola Vaccine Trial
T-7Deb ZarinEverything You Always Wanted to Know About ClinicalTrials.gov
T-8Bryan LuceThe Pragmatic Clinical Trial Meets the Learning Healthcare System
Keynote AddressSteven AndersonRegulatory Science: Innovations in Assessing Effectiveness, Safety and Benefit-Risk for Biologics
W-1Mo Huque & Sirisha MushtiAlpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials

1:00 – 4:00 PM

Online Short Course: Building Your Career as a Statistician, presented by Dr. Craig Mallinckrodt, Pentara

8:30 AM

Applications of Unsupervised Learning for Plasma Concentration-Time Curves, presented by Junghi Kim,Senior Mathematical Statistician, Division of Biometrics VIII, Office of Biostatistics, FDA

9:30 AM

Emerging Digital Technology Data from Continuous Glucose Monitoring in Anti-Diabetic Product Clinical Trials, Yoonhee Kim, Lead Mathematical Statistician, Diabetes Statistical Review Team, Division of Biometrics II, Office of Biostatistics, FDA

11:00 AM

Interpretable Machine Learning – Applications in Clinical Research, Presented by Dr. Kao-Tao Tsai

9:00 AM

Keynote Address: Building Your Career in Statistics: A Guide to Accomplishment, Happiness, and Longevity, presented by Dr. Craig Mallinckrodt, Pentara

10:00 AM

Follow-Up Planning for Time to Event Endpoints in Randomized Cancer Trials: Learnings for RWE Studies, presented by Shankar Srinivasan, Bayer U.S. LLC