Blog – BASS XXXI

2022

BASS XXIX Tutorials and Keynote Address presentations:

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

2021

BASS XXVIII Tutorials and Keynote Address presentations:

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

2020

BASS XXVII Tutorials and Keynote Address presentations:

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

2019

BASS XXVI Tutorials and Keynote Address presentations:

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

2018

BASS XXV Tutorials and Keynote Address presentations:

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

2017

BASS XXIV Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
Keynote Address	Vernon M. Chinchilli	N-of-1 Trials: Do They have a Role in Clinical Research?
M-1	C V Damaraju	Pragmatic Trials - Shifting to a New Normal
M-2	Nitis Mukhopadhyay	Introductory Sequential Methodologies with Applications
M-3	Satrajit Roychoudhury	Impact of Non-proportional Hazard in Confirmatory Trial Design and Analysis for Oncology
M-4-M-5	Craig Mallinckrodt,Bohdana Ratitch,Ilya Lipkovich and Lu Zhang	Preparing 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-1	Jing Zhao	Bayesian Approach for Neoadjuvant/Adjuvant Oncology Trials
T-2	Shankar Srinivasan, Lihua Yue, and Rick Soong	Some Methods for Longitudinal and Cross-Sectional Visualization with Further Applications in The Context of Heat-Maps
T-3-T-4	Ramses Sadek	Considerations for Oncology Clinical Trials
T-5	Qing Liu	An Evidential Paradigm for Experiments
T-6	Jiajun Liu, Eric Nantz	Overview of Multiplicity Adjustment Issues in Clinical Trials and Examples
W-1-W-3	Mark Rothmann	Non-inferiority Trials to Establish Effectiveness
W-1	Aloka Chakravarty	ICH E17 and Multi-Regional Clinical Trials (MRCTs)
W-2	Yoko Tanaka	Topic from ICH-E17 Draft Guideline on Multiregional Clinical Trials (MRCT)‑Subpopulation‑Think Deeper

2016

BASS XXIII Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
Keynote Address	Janet Wittes	Learning from Extroverts, or Assuming Statistical Leadership
M-2	Kao-Tai Tsai	Joint Modeling of Time-to-and Laboratory Test Data Trial
M-3	Richard Zink	Uncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials
M-4	Vance Berger	Comparable comparison Groups in Randomized Clinical Trials
M-5	Dungang Liu	Meta-analysis of Rare Events in Drug Safety Studies: A Unifying Framework for Exact Inference
M-6	Gheorghe Doros	Clinical Trial Designs for Placebo Response in Clinical Trials for Psychiatric Disorders
M-7	William R. Prucka	Innovative Designs and Analyses for Pediatric Drug Development
Keynote Address	Ralph B. D'Agostino, Sr.	Comments and Reflections on Issues in Clinical Trials:Both Design and Analysis:Past, Present and Future
T-2	Bohdana Ratitch	Analysis Strategies for Clinical Trials with Treatment Non-Adherence
T-3	Gerhardt Pohl, Anthony Zagar	Real World Evidence-Generalizability and Propensity Scoring
T-4	Mat D. Davis	Current and Future States of the DIA Bayesian Scientific Working Group Education Effort
T-5	Shankar Srinivasan, Vatsala Karwe	Tepee Plots: A Novel Statistical Descriptive Graphical Technique for Representating Tabular Data
T-6	Steven Gilbert, Zorayr Manukyan	Bayesian Dynamic Borrowing
W-1	Yi 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-2	ShanMei Liao, Bo Jin, Yi Tsong, Meiyu Shen and Cassie(Xiaoyu) Dong	Tipping Point Analysis- Considerations for Missing Data in Biosimilars & Biosimilars

2015

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

2014

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

2013

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