14th Annual University of Pennsylvania Conference on Statistical Issues in Clinical Trials / Subgroup Analysis in Clinical Trials:   Opportunities and Challenges

Tuesday, April 12, 2022

8:30am to 4:30pm (EDT)

Virtually via BlueJeans



Please note:
  • Once registered, each registrant will receive a unique URL to join the conference
  • The URL is NOT to be transferred or shared with non-registrants in any way


  • PENN faculty and students: $0
  • Academic, Government, Non-Profit:  $60
  • Industry:  $85
  • Non-PENN students:  $25


David Kent, MD (Tufts University)

Overall Average Treatment Effects and One-Variable-at-a-Time Subgroup Analysis: The Scylla and Charybdis of Evidence Based Medicine

Ellis Unger, MD (Consultant)

An "Unofficial" US Regulatory Perspective

Tom Fleming, PhD (University of Washington)

Exploratory Subgroup Analyses:  Why do we Need Particular Caution?

Lisa McShane, PhD (NCI) 

Finding the (biomarker-defined) subgroup of patients who benefit from a novel therapy: no time for a game of hide and seek


Noah Simon, PhD (University of Washington)

Adaptive Enrichment Trials: Identifying the 'right' subgroup

Anastasia Ivanova, PhD (UNC)

Methodological Challenges in PrecISE (Precision Interventions for SEvere asthma)

Ilya Lipkovich, PhD (Eli Lilly)

Comparison of Recent Approaches for Subgroup Identification from Clinical and Observational Data

Patrick Schnell, PhD (Ohio State)

Multiplicity Considerations for Analyses of Non-Exchangeable Subgroups



Mark Rothmann (FDA) 

Heterogeneity of Treatment Effects in Clinical Trials

Kosuke Imai (Harvard) 

Statistical Inference for Subgroups Discovered by Machine Learning

Kit Roes (European Regulatory Perspective) 

Panel Discussion Slides

Michael Rosenblum (Johns Hopkins) 


Janet Wittes (Statistics Collaborative, Inc.) 

Evolving Thoughts on Subgroups


  • To view or download presentation slide sets, please click on the speaker TOPIC above. 
  • To view short biographies for each speaker/panelist, please click on their NAME above. 


American Statistical Association - 2022 Annual Meeting Information   
Society for Clinical Trials - 2022 Annual Meeting Information
National Institute of Statistical Sciences - 8th Workshop on Biostatistics and Bioinformatics, 2022  



For additional information, contact:
Janine Pritchard
Phone: 215-573-4045 | Email: jpritcha@pennmedicine.upenn.edu

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How can we answer and anticipate the pressing health issues we face together as a society? At the CCEB we rise to that challenge through research and training in epidemiology and in biostatistics. We solve problems facing patients and populations. READ MORE ABOUT CCEB



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