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