2025

BASS XXXII Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
Keynote AddressDr. Stephan Ogenstad Trials and Tribulations: The Good, The Bad, and The Patently Absurd
M-1Dr. Daniel Backenroth Leveraging Baseline Covariate Adjustment Methods in
Oncology Time-to-Event Studies
M-2Dr. Fei Chen Driving Operational Excellence: The Power of Statistical Innovation in
Clinical Development
M-3Dr. Ekaterina Smirnova
 Bile Acids Are the Strong Indicators for the Progression of Metabolic
Dysfunction Associated Steatotic Liver Disease in Ethnically Diverse Populations
M-4Dr. George Kordzakhia Integrated Analysis of Pre-Marketing Safety Data,
Statistical Considerations and Estimands
T-1Dr. Benjamin Duncan Evaluating Frequentist and Bayesian Confidence Intervals for
Study Size Adjusted Risk Difference
T-2Dr. Melvin Munsaka Enhancing the DMC Data Package Using Open Source
Software, Artificial Intelligence, and Large Language Models
T-3Dr. Ryan Butterfield and Dr. Edward DeVol A Structured Approach to Designing Pivotal Diagnostic Accuracy
Studies for Noninvasive Tests Using Meta-Analytic Techniques
T-4Dr. Yevgen Tymofyeyev and Dr. Michael Grayling Multiple Testing in the Context of Group Sequential Designs
T-5Dr. Priyam Das SMART-MC: Characterizing the Dynamics of Multiple Sclerosis
Therapy Transitions Using a Covariate-Based Markov Model
T-6Dr. Stephan Ogenstad, Co-Authored by Greg Ginn Harnessing Simulation to Inform Endpoint Selection in
Cardiovascular Trials
W-1Dr. Emily Morris Rare Disease Clinical Trials: Challenges and Opportunities
W-2Dr. Weimeng Wang Collecting and Applying Evidence to Interpret Clinical Outcome
Assessments (COA)-based Endpoints in Clinical Trials

2024

BASS XXXI Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
Keynote AddressCraig Mallinckrodt Building your career in statistics: A guide to accomplishment, happiness, and longevity
M-1Ryan Butterfield & Viral Panchal Case Study of a Clinical Trial
Focusing on Missing Data Issues
M-2Ibrahim Turkoz Up-Front Matching for
Prospective Observational Studies to Mimic Randomization
M-3Gary Cline Optimizing Drug Development Designs
for Precision Medicine Considerations
M-4Greg Ginn Real-World Data for Enhanced Drug
Development in the Pharmaceutical Industry
M-5Roy Sabo Using skeptical and informative priors
in Bayesian adaptive clinical trial designs
T-1Shankar Srinivasan Follow-up for time to event endpoints in randomization trials: Learnings for RWE studies
T-2Lira Pi From the Discovery Stage of
Understanding Potential Drug’s Targets of Genetic Disorders and the Development of Gene Therapies, Manufacturing, and Comparability
T-3Quang Nguyen Follow-up for time to event endpoints in randomization trials: Learnings for RWE studies
T-5Zhi Yang Long Term Efficacy and Safety
T-6Laura Morrison Statistical techniques and learnings from GVHD treatment trials
W-1Junghi Kim Applications of Unsupervised
Learning for Plasma Concentration-Time Curves
W-2Yoonhee Kim Emerging Digital Technology Data
from Continuous Glucose Monitoring in Anti-Diabetic Product Clinical Trials
W-3Kao- Tao Tsai Explaining Machine Learning Outputs

2023

BASS XXX Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
Keynote AddressFrank Rockhold Clinical Trials Using Patient Health Data: A Primer on Pragmatic Trials
M-1Joseph C. Cappelleri Advances in Interpretation of Patient-Reported Outcomes
M-2Sarah Stanley Pediatric Trial Design:
Opportunities, Challenges, Bioethics and Innovation
M-4Ryan Butterfield The Future of Statistical Analysis -- to AI or not AI?
T-1Tianle Chen Statistical Leadership in Establishing Surrogacy: Applications and Refl ections
T-2Yannis Jemiai Simulation-guided Designs: A New Approach to Trial Design and Probabilistic Risk AssessmentAbstract:
T-3Juhua Luo SGLT2 Inhibitors and Cancer Prognosis – Using SEER-Medicare Linked Data

2022

BASS XXIX Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
Keynote AddressLisa LaVange Leadership in Innovation and Collaboration
M-1Steve Ruberg The Epistemological Superiority of Bayesian Inference Over Frequentist Inference
M-2Brian Hobbs Leveraging Historical Controls Using Multi-source Adaptive Design
M-4Kao-Tai Tsai, Network Analysis of RNA Sequence and Drug Safety Data
T-1Brent McHenryCombination Complexities, Contribution of Components Considerations in Cancer: Gleanings from Interactions with Health Authorities at Various Stages of Development
T-2Jing Zhao Contribution of Components in Different Perspectives: From Individual Investigational Drugs and From Different Treatment Periods
T-3Jinjie Chen DOME: A Bayesian Optimal Design for Randomized Dose Expansion Cohorts in Oncology Trials
T-4Parvin Fardipour Sample Size Re-estimation in the Context of Dual Endpoints Using a Promising Zone Approach – Illustrated with Two Pharmaceutical Case Studies
T-5Shankar Srinavasan Inverse Propensity Score-Based Weighting Methods to Remove Bias in Observational Studies
T-6Ben Duncan Robust Safety Monitoring and Signal Detection Using Alternatives to the Standard Poisson Distribution
W-1Rebecca Hagar Recommendations and Considerations for Umbrella and Platform Trials
W-2Cesar Torres A CDER Reviewer's Experience With COVID-19 Programs
W-3Xin Wang Overall Type I Error Control for Seamless Phase II/III Adaptive Design using Biomarkers

2021

BASS XXVIII Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
Keynote AddressRon WassersteinHave we Started Moving to a World Beyond p<0.05?
M-1Vlad Dragalin Complex Innovative Design
M-2Laura Gunn SMART Treatment Decisions: Predicting 10-Year Cardiovascular Event Risks & Assessing Treatment Thresholds in a UK Population
M-3Jose Pinheiro Improving Dose Finding Studies in Drug Development: the MCPMod Approach
M-4Alex Sverdlov Optimal Designs for Clinical Trials: Their Purpose, Utility, and Applications
M-5Mark van der Laan Targeted Learning for Causal Inference Based on Real World Data
T-1Manyun Liu and Roshni Modi Relationship between Overall Survival, Clinical and Genomic data from TCGA's Study on Pancreatic Cancer Patients via Machine Learning
T-2Frank Rockhold Randomized Pragmatic Clinical Trials Utilizing RWD: Myths & Realities
T-3Frank RockholdCOVID Lessons Learnt
T-4Gary Cline Implementing Statistical and Data Science Innovative Approaches in Drug Development
T-5Demissie Alemayehu Challenges and Opportunities with Decentralized Trials: Statistical Perspectives
T-6Fanni Natanegara Decentralized Clinical Trials- Statistical and Data Considerations
T-7Melanie Poulin-CostelloStatistical Considerations in Decentralized Trials
W-1Lei NieStatisticians Face Challenges and Opportunities in Drug Development
W-2Andrew Potter Considerations for Analysis of Data Collected by Wearable Digital Health Technology in Clinical Trials
W-3Satrajit Roychoudhury and Kenneth KouryA Seamless Design to Rapidly Evaluate Vaccine Candidates for COVID-19

2020

BASS XXVII Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
Keynote AddressMichael O'Connell Modelling the COVID-19 Pandemic
W-2Qing Liu and Karl Peace Statistical Considerations for Clinical Trials During the COVID-19 Pandemic
W-3Yongming Qu and Ilya Lipkovich Estimands and Estimation for Clinical Trials Beyond the COVID-19 Pandemic
W-4Yue Shentu Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic
W-5Mat Makowski A Clinical Trial in Response to a Pandemic
T-1Inna Perevozskaya and Magdalena Zwierzyna Predicting the COVID-19 Pandemic Impact on Clinical Trial Recruitment
T-2Daniel Janies and Samuel Handelman Genomics Enabled Repurposing of Approved Compounds as Countermeasures to SARS-CoV-2
T-3Mark Levenson and Daniel Rubin Statistical Issues in Regulatory Guidances on COVID-19 Clinical Trials and Clinical Trials Impacted by COVID-19
T-4Pranab Ghosh Sample Size Re-estimation for COVID-19 Trials and Analyses Techniques for Unique Endpoints

2019

BASS XXVI Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
Keynote AddressDr. Sally C. Morton A Statistical Leadership Journey
M-1Chenkun Wang and Ziliang Li A Practical Review of Real World Data for Effectiveness Decisions – Case Studies of Using Historical Data in Developing Novel Therapies by DIA NEED
M-2Stephan Ogenstad Artificial Intelligence and its Impact on Clinical Trials
M-3Kaushik Patra Power Considerations for Clinical Trials in Presence of Multiplicity
M-5Zachary Skrivanek Tutorial on Data Visualization
M-6Laura Gunn Assessing Treatment Effect Using Propensity Score Matching within the U.K. Population of Crohn's Disease Patients
T-1Pranab Ghosh Platform Trials in Confirmatory Settings
T-2Alan Menius Taking Adherence, PROs and RWD into Account in Clinical Trials
T-3Lothar Tremmel Aggregate Safety Analysis for Causality Assessments of SAEs
T-4Shankar Srinivasan Overview of Some Key Methods for Observational Studies
T-5Qing Liu Innovative Designs for Drug Development in Rare Diseases
T-6Jack Knorr The Benefits and Risks of Borrowing Historical Placebo Data in Early Phase Randomized Control Trials
W-1Daniel Rubin
 Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes Guidance for Industry
W-2Gregory Levin Adaptive Design Clinical Trials for Drugs and Biologics
W-3Kao-Tai Tsai Gene Expression-Based Precision Medicine

2018

BASS XXV Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
Keynote AddressDr. Karl E. Peace Joint Modeling of Time-to-and Laboratory Test Data Trial
M-1Joe Cappelleri Methods for Interpretation of Patient-Reported Outcomes
M-2Benjamin DuncanSafety Signal Detection: For Ongoing Clinical Trials, Utilizing a Bayesian Framework
M-3Ronald Wasserstein ASA’s Statement on P-values
M-5David KerrData Monitoring Committee Overview
M-6Matt DownsData Monitoring Committee
T-1Neal Thomas Design Stratification
T-2Keaven Anderson Non-proportional hazard models
T-3Abdullah Masud Evaluating treatment efficacy by combining multiple measures in clinical trial applications
T-4Ramses Sadek Oncology Adaptive Clinical Trials: Real Life Applications
T-5Vlad Dragalin Estimand
T-6Macaulay OkwuokenyeMultinational Real-world Studies in the Biopharmaceutical Industry: Design, Analysis, Issues, and Case studies
W-1Ling Chen
 Statistical Assessment of Abuse-deterrent Opioid Drug Products
W-2Hana LeeStudies to Evaluate the Risk of Abuse and Overdose for Prescription Opioids in the Real World
W-3Melvin MunsakaAdvanced Visual Analytics of Safety Data from Different Data Sources

2017

BASS XXIV Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
Keynote AddressVernon M. ChinchilliN-of-1 Trials: Do They have a Role in Clinical Research?
M-1C V DamarajuPragmatic Trials - Shifting to a New Normal
M-2Nitis MukhopadhyayIntroductory Sequential Methodologies with Applications
M-3Satrajit RoychoudhuryImpact of Non-proportional Hazard in Confirmatory Trial Design and Analysis for Oncology
M-4-M-5Craig Mallinckrodt,Bohdana Ratitch,Ilya Lipkovich and Lu ZhangPreparing for the New ICH E9 Guidance on Estimands and Sensitivity
Prevention of Missing Data in Clinical Trials Informed by Statistical Learning from Past Clinical Trials
Multiple Imputation Strategies for Evaluating Long-Term Efficacy Based on Catagorical Outcomes in Longitudinal Clinical Trials
A Practical Implementation of Multiple Imputations for Analysis of Long-Term Categorical Outcomes from Ixekizumab UNCOVER-3 Study
T-1Jing ZhaoBayesian Approach for Neoadjuvant/Adjuvant Oncology Trials
T-2Shankar Srinivasan, Lihua Yue, and Rick SoongSome Methods for Longitudinal and Cross-Sectional Visualization with Further
Applications in The Context of Heat-Maps
T-3-T-4Ramses SadekConsiderations for Oncology Clinical Trials
T-5Qing LiuAn Evidential Paradigm for Experiments
T-6Jiajun Liu, Eric NantzOverview of Multiplicity Adjustment Issues in Clinical Trials and Examples
W-1-W-3Mark Rothmann Non-inferiority Trials to Establish Effectiveness
W-1Aloka ChakravartyICH E17 and Multi-Regional Clinical Trials (MRCTs)
W-2Yoko TanakaTopic from ICH-E17 Draft Guideline on Multiregional Clinical Trials (MRCT)‑Subpopulation‑Think Deeper

2016

BASS XXIII Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
Keynote AddressJanet WittesLearning from Extroverts, or Assuming Statistical Leadership
M-2Kao-Tai Tsai Joint Modeling of Time-to-and Laboratory Test Data Trial
M-3Richard ZinkUncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials
M-4Vance BergerComparable comparison Groups in Randomized Clinical Trials
M-5Dungang LiuMeta-analysis of Rare Events in Drug Safety Studies: A Unifying Framework for Exact Inference
M-6Gheorghe DorosClinical Trial Designs for Placebo Response in Clinical Trials for Psychiatric Disorders
M-7William R. PruckaInnovative Designs and Analyses for Pediatric Drug Development
Keynote AddressRalph B. D'Agostino, Sr.Comments and Reflections on Issues in Clinical Trials:Both Design and Analysis:Past, Present and Future
T-2Bohdana RatitchAnalysis Strategies for Clinical Trials with Treatment Non-Adherence
T-3Gerhardt Pohl, Anthony ZagarReal World Evidence-Generalizability and Propensity Scoring
T-4Mat D. DavisCurrent and Future States of the DIA Bayesian Scientific Working Group Education Effort
T-5Shankar Srinivasan, Vatsala KarweTepee Plots: A Novel Statistical Descriptive Graphical Technique for Representating Tabular Data
T-6Steven Gilbert, Zorayr ManukyanBayesian Dynamic Borrowing
W-1Yi Ysong and Meiyu Shen Analytical Biosimilar Assessment: Current Practice and Draft Guidance, Three Biosimilar Advisory Committee Meetings & Analytical Biosimilar Assessment: Frequently Discussed Statistical Issues
W-2ShanMei Liao, Bo Jin, Yi Tsong, Meiyu Shen and Cassie(Xiaoyu) Dong Tipping Point Analysis- Considerations for Missing Data in Biosimilars & Biosimilars