The 2022 workshop offered 10 half-day short courses Tuesday, September 20. The short courses are ticketed events that can be added to your registration for an additional fee.
Morning Short Courses
8:30 a.m. – 12:00 p.m.
SC01: Nuts and Bolts of Defining Estimands and Constructing Estimatiors Based on ICH E9 Addendum (R1)
Yongming Qu, Eli Lilly and Company, and Ilya Lipkovich, Eli Lilly and Company
SC02: Leveraging External Data Through Bayesian Methods in Clinical Trials
Ying Yuan, MD Anderson Cancer Center, and James Travis, US Food and Drug Administration
SC03: Improving Precision and Power in Randomized Trials by Leveraging Baseline Variables
Michael Rosenblum, Johns Hopkins Bloomberg School of Public Health; Kelly Van Lancker, Johns Hopkins Bloomberg School of Public Health; and Josh Betz, Johns Hopkins Bloomberg School of Public Health
SC04: Design Considerations and Statistical Methods for Vaccine Clinical Trials
Wenji Pu, GSK; Ivan Chan, AbbVie; Jonathan Hartzel, Merck & Co.; and Fabian Tibaldi, GSK
SC05: R for Clinical Study Reports and Submission
Yilong Zhang, Merck & Co.; Nan Xiao, Merck & Co.; and Keaven Anderson, Merck & Co.
Afternoon Short Courses
1:30 p.m. – 5:00 p.m.
SC06: Estimand Framework Implementation
Gregory Levin, US Food and Drug Administration; John Scott, US Food and Drug Administration; and Susan Mayo, US Food and Drug Administration
SC07: Use of External Data in Clinical Trials: Unleashing the Power of Information
Satrajit Roychoudhury, Pfizer, and Ram Tiwari, Bristol Myers Squibb
SC08: Leveraging Real-World Data in Medical Product Clinical Trials Design and Analysis
Chenguang Wang, Johns Hopkins University; Nelson Lu, US Food and Drug Administration; and Wei-chen Chen, US Food and Drug Administration
SC09: Estimating Treatment Effect in a Principal Stratum: Applications of Causal Inference to the Tripartite Estimand Approach (TEA) and Early Biomarker Response
Stephen Ruberg, Analytix Thinking, Purdue University, and Arman Sabbaghi, Purdue University
SC10: Cell and Gene Therapy: Concepts, Rationale, Statistical Issues, and Regulatory Considerations
Weidong Zhang, Jounce Therapeutics; Srinand Ponnathapura Nandakumar, Nurix Therapeutics; and Lynn Navale, Allogene Therapeutics