Webinar Archive


Statistical Considerations for Tumor Agnostic Drug Development, Cindy Lu & Kui Shen

Diversity in Clinical Trials, Mark Rothmann

Statistical Translation of Extrapolation: demonstrating efficacy and safety of investigational medicines in pediatric populations, James Travis, Jingjing Ye & Margaret Gamalo

Scientific Evaluation of Safety Data and Aggregate Safety Assessment Planning for IND Safety Reporting, Greg Ball, Jacqueline Corrigan-Curay, Barbara Hendrickson & Brian Waterhouse

ASA-DIA Safety Working Group, Hong Yang, Leo Plouffe, Lisa R. Rodriguez & Mike W. Colopy

Interdisciplinary Safety Evaluation for Learning and Decision-Making: Education for Executives, Greg Ball, Jacqueline Corrigan-Curay, Barbara Hendrickson & Sheila Mahoney-Jewels

Benefits of joining our community of stats in small biotech, Liang Fang, Mohamed Hamdani, Alan Hartford, Sharon C. Murray & Alan Y. Chiang


ASA BIOP JSM Contributed Paper Award Webinar Series, Wenting Cheng & Mary Ryan
Variance estimation for the Kappa statistic in the presence of clustered data and heterogeneous observations, Mary Ryan
A Cardiologist and a Statistician Walk into a DMC, Janet Wittes & Marc Pfeffer
Graphical approaches for the control of generalized error rates, Frank Bretz
Generalized pairwise comparisons for benefit/risk assessment in personalized medicine, Marc Buyse & Julien Péron
Understanding hypothetical strategies and defining the clinical question of interest, Frank Bretz & Lei Nie
A Bayesian phase I/II platform design for co-developing drug combination therapies for multiple indications, Ying Yuan
Putting Pharmacovigilance into Action. Frank W. Rockhold & Tjark Reblin
Joint PSI, EFSPI & ASA BIOP Webinar: Complex Innovative Designs, John Scott, Olivier Collignon, & Heinz Schmidli
Response Assessment in Cancer Clinical Trials, Mithat Gonen & Lawrence Schwartz


Subgroup Analysis Identification: The Hardest Problem There Is, Stephen Ruberg
Mini-symposium on Real World Data/Real World Evidence, Weili He, Martin Ho & Diqiong Xie
Hazards of Hazard Ratios in Survival Analysis, L.J. Wei
Survival Analysis Using a 5-STAR Approach in Randomized Clinical Trials, Devan Mehrotra
Incorporate External Control Data in New Clinical Trial Design and Analysis, Lanjun Zhang
The Leadership Laboratory: Using Observational Study to Develop Leadership Skills for Statisticians, Gary Sullivan
Biopharmaceutical Section Offers Advice on Strategic Planning for ASA Fellow Nomination, Ivan Chan, Paul Gallo, Christy Chuang-Stein & Stephen Ruberg
Detangle Modern Dose-Finding Designs: A Tutorial, Ji Yuan
Biomarker Analysis in Clinical Trials Using R, Nusrat Rabbee
ESPSI-PSI-BIOP Joint Webinar on Estimands, John Scott, Andreas Brandt, Evgeny Degtyarev & Vladimir Dragalin


Bayesian Inference for a Principal Stratum Sstimand to Assess the Treatment Effect in a Subgroup Characterized by Post-Randomization Events, Baldur Magnusson & Frank Bretz
Wearable and Implantable Technology (WIT) with Biopharmaceutical Applications, Ciprian Crainiceanu
Incorporating Innovative Techniques Toward Extrapolation and Efficient Pediatric Drug Development, Margaret Gamalo
Basket Trials in Oncology, Mithat Gonen
Platform Trials - Software and Operational Solutions, Kyle Wathen
Generating and Harnessing RWE, HIT and AI in the Era of Big Data, Kelly Zou, Jim Li & Nikuj Sethi
Assessing When Electronic Health Records or Claims Databases Are Fit for a Specific Research Question or Regulatory Purpose, Cynthia Girman
Approaches for Estimating Treatment Effect in Principal Strata Where an Intercurrent Event Confounds the Measure of Primary Interest with Examples, Bohdana Ratitch, Michael O'Kelly & Ilya Lipkovich
Leveraging Longitudinal Data in Drug Development via Mixed-Effects Modeling, José Pinheiro
Model-Based Meta-Analysis (MBMA): Harnessing Public External Data to Improve Internal Decision-Making, Matthew Zierhut


Advancing the Interpretation of Patient-Reported Outcome Data, Joseph Cappelleri, Lisa A. Kammerman & Kathleen W. Wyrwich
Thirty years of Numbers Needed to Treat (NNT): Why They Don't Mean What Many People Think They Do, Stephen Senn
Adaptive Enrichment Trial Designs: Statistical Methods, Trial Optimization Software, and Case Studies, Michael Rosenblum
Assessing Biosimilarity and Interchangeability: Issues and Recent Development, Shein-Chung Chow
An Innovative Design to Combine Proof-of-Concept and Dose Ranging, Naitee Ting & QiQi Deng
Use of Historical Data in Clinical Trial: An Evidence Synthesis Approach, Satrajit Roychoudhury & Sebastian Weber
Pragmatic Benefit:Risk Evaluation: Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes, Scott Evans


An Introduction to Bayesian Nonparametric Methods for Causal Inference in Pharmacoepidemiology, Jason Roy
Bayesian Biopharmaceutical Applications Using SAS, Fang Chen & Frank Liu
Sequential and Adaptive Analysis with Time-to-Event Endpoints, Scott S. Emerson
Statistical Methods for Dynamic Treatment Regimens and Sequential Multiple Assignment Randomized Trial, Abdus S. Wahed & Yu Cheng
Key Multiplicity Issues in Clinical Trials, Alex Dmitrienko
Introduction to Statistical Approaches to Comparative Effectiveness Research, Sharon-Lise Normand
Building a Bayesian Decision-Theoretic Framework to Design Biomarker-Driven Studies in Early Phase Clinical Development, Danny Yu
Quantitative Sciences for Safety Monitoring during Clinical Development, Greg Ball, Judy Li & William Wang
Regression Models for Censored Data: When it's NOT a good idea to use PH, AFT and other such models?, Sujit Ghosh


Bayesian Methods for Evidence Synthesis and Network Meta-Analysis, Brad Carlin
Statistical Methods to Test for Biosimilarity, Sujit K. Ghosh
Machine Learning and Precision Medicine, Michael R. Kosorok
An Overview of Statistical Considerations in Clinical Validation of Companion Diagnostic Devices of Precision Medicine, Meijuan Li
Global Sensitivity Analysis of Randomized Trials with Informative Drop-out, Daniel Scharfstein & Aidan McDermott
Introduction to Stan - From Logistic Regression to PK/PD ODE Models, Sebastian Weber
Basket Design of Phase III Confirmatory Trials, Cong Chen
Confirmatory Adaptive Designs, Franz König & Martin Posch


Graphical Approaches to Multiple Testing, Frank Bretz & Dong Xi
Statistical Methods Used in Pre-Clinical Drug Combination Studies, Wei Zhao
Interpretation of Patient-Reported Outcomes, Joseph Cappelleri
Propensity Score Methods for Estimating Causal Effects in Pharmaceutical Research, Elizabeth Stuart
Bayesian Methods for Drug Safety Evaluation and Signal Detection, David Ohlssen & Amy Xia
Evaluation of Biomarkers and Risk Prediction Models for Binary Outcomes, Katie Kerr
Nonlinear Mixed Effects Models with Applications in Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling, Sandeep Dutta & Balakrishna Hosmane
Clinical Trial Designs for Validating Prognostic and Predictive Markers in Oncology, Daniel J. Sargent


Use of Historical Data in Designed Experiments, Beat Neuenschwander & Heinz Schmidli
Statistical Aspects of Long Term Safety Cohort Studies, Girish (Gary) Aras
Survival Analysis: Overview of Nonparametric, Parametric, and Semiparametric Approaches, Joseph Gardiner
Overview, Hurdles, and Future Work in Adaptive Design, Christopher Coffey
Modeling and Simulation Approach to Optimize the Assessment of the Potential for QT Prolongation, Daniel Weiner
Design and Analysis of Biomarkers Studies for Risk Prediction, Tianxi Cai
Bayesian Combination Dose Finding in Phase I: Concepts and Applications, Simon Wandel & Suman Sen
From Sample Size Calculations to Clinical Trial Optimization, Alex Dmitrienko & Gautier Paux


Design and Analysis of Studies of Health-Related Quality of Life, Diane Fairclough
Subgroup Analysis in Clinical Trials, Alex Dmitrienko & Ilya Lipkovich
An Introduction to Joint Models for Longitudinal and Time-to-Event Data, Dimitris Rizopoulos
DSMBs/DMCs, Scott Evans
Detecting Safety Signals Among Adverse Events in Clinical Trials, Richard C. Zink
Randomization and Minimization in Clinical Trials, Stephen Senn
Signal Detection Methods for Large Drug Safety Reporting Databases, Ram Tiwari


Impact of Phase 2 Dose-finding Study Design on Phase 3 Probability of Success and Net Present Value, Jim Bolognese & Nitin Patel
Comparing Strategies for Trials with High Placebo Response, Anastasia Ivanova
Bayesian Evidence Synthesis in Drug Development, David Ohlssen & Heinz Schmidli
Introduction to Pharmacokinetic/Pharmacodynamic Modeling for Statisticians, Alan Hartford


Group Sequential Design Basics with Application using the gsDesign R Package and its GUI, Keaven Anderson
Introduction to Bayesian Statistics, Joseph Ibrahim
Bayesian Model-based Approaches for Single and Combination Dose Finding, Stuart Bailey & Beat Neuenschwander
Handling Missing Data in Clinical Trials, Mike Kenward
Sensitivity Analyses that Address Missing Data issues in Longitudinal Studies for Regulatory Submission, James Roger
Bayesian Methods for Non-inferiority Tests and Sample Size Determinations, Sujit K. Ghosh


Non-parametric Dose Response Models in Bayesian Adaptive Designs, Andrew P. Grieve
Data Monitoring in Practice: Making your Data Monitoring Committee Effective, Matt Downs & Janet Wittes
An Introduction to the Nonlinear Mixed Effects Model and Pharmacokinetic/Pharmacodynamic Analysis, Marie Davidian
Statistical Analysis of Short-term Studies in Regulatory Toxicology Using R, Ludwig A. Hothorn
A Predictive Approach to Process Optimization with Applications to Pharmaceutical Development and Manufacturing, John Peterson


Classical Sample-size Analysis for Hypothesis Testing (Part I), Ralph O'Brien & John Castelloe
Classical Sample-size Analysis for Hypothesis Testing (Part II), Ralph O'Brien & John Castelloe
Microarray Data Analysis, Dhammika Amaratunga & Javier Cabrera
Case Study in Parametric Survival Modeling, Frank E. Harrell, Jr 
Another Look at Stratified Analysis of Binary Data, Christy Chuang-Stein
Design and Analysis of Count Data, Mani Lakshminarayanan
Large-scale Significance Testing of Genomic Data, John Storey
Genomic Data Analysis with Targeted Maximum Likelihood and Super Learning, Mark van der Laan
Use of Genomics and Predictive Biomarkers in the Design and Analysis of Phase III Clinical Trials, Richard Simon
Introduction to Hierarchical Bayes Methods for Data Analysis, Brad Carlin


Statistical Evaluation of Surrogate Endpoints in Clinical Trials: Setting the Scene, Geert Molenberghs
Statistical Evaluation of Surrogate Endpoints in Clinical Trials: Meta-analytic Framework, Geert Molenberghs
Statistical Evaluation of Surrogate Endpoints in Clinical Trials: Towards Unification, Geert Molenberghs
Assessment of QTc Prolongation in Clinical Drug Development, Alex Dmitrienko
Stratified Analyses: Tips for Improving Power, Devan V. Mehrotra
Bioequivalence, Scott Patterson & Byron Jones