The 2nd Symposium on Early Phase Trial Design Methodology 26-28 April 2017
University of Virginia, Charlottesville, VA
The Symposium
Three Days of Talks Beginning...
26 April 2017
Noon
The conference will have a mix of presentations on new methodologies for the design of early stage trials and practical considerations in implementing novel designs in practice. Dr. Steven Piantadosi will be the keynote speaker. Invited participants will be a mix of new and experienced researchers from the FDA, pharmaceutical industry and academia. This symposium is jointly sponsored by the University of Virginia (UVA) Department of Public Health Sciences and the UVA Cancer Center.
Location: UVA Newcomb Hall, 180 McCormick Rd, Charlottesville, VA
​
Organizing Committee:
Mark R. Conaway, Bethany J. Horton, Gina R. Petroni, Nolan A. Wages
Schedule of Events
Wednesday, April 26
Location for presentations: Newcomb Hall Ballroom - Third Floor
​
12:00 Mark Conaway & Nolan Wages - University of Virginia
Welcome and Introduction
12:30 Anastasia Ivanova - University of North Carolina at Chapel Hill
The Rapid Enrollment Design (RED) for Phase I Clinical Trials
1:00 Nate O’Connell - Medical University of South Carolina
A latent variable approach to elicit toxicity severity weights for multiple toxicities in cancer clinical trials
1:30 Alexia Iasonos - Memorial Sloan Kettering Cancer Center
Phase I Designs that Allow for Uncertainty in the Attribution of Adverse Events
​
2:00 Break
​
2:30 Pavel Mozgunov - University of Lancaster
A Non-parametric Information-Theoretic Approach for Phase I/II Clinical Trials
3:00 Yisheng Li - MD Anderson Cancer Center
Novel Bayesian Dose-finding Designs Accounting for the Schedule Effects by Using Pharmacokinetic/Pharmacodynamic Modeling
3:30 Mitchell Thomann - Eli Lilly & Company
A Practical Comparison of Phase 2 Dose-Response Analysis Methods
4:00 Kristen Cunanan - Memorial Sloan Kettering Cancer Center
Adaptive Designs in Phase II Basket Clinical Trials
​
4:30 Break
​
5:00 Steve Piantadosi - Keynote Address
Can Early Development Be Optimized?
​
6:00 Reception Location: Newcomb Hall - South Meeting Room
​
Thursday, April 27
Location for presentations: Newcomb Hall - Commonwealth Room
​
9:00 Graham Wheeler - University College of London
Toxicity-Dependent Feasibility Bounds for the Escalation with Overdose Control Approach in Phase I Cancer Trials
9:30 Ruitao Lin - University of Washington
Nonparametric Overdose Control in Phase I Dose-Finding Clinical Trials
10:00 Andre Rogatko - Cedars-Sinai Medical Center
Comparison between Continuous and Discrete Doses Using Escalation With Overdose Control
​
10:30 Break
​
11:00 Ying Yuan - MD Anderson Cancer Center
A Bayesian Phase I-II Design to Find the Optimal Biological Dose for Immunotherapy Trials
11:30 Ken Cheung - Columbia University
Individualized Dose Finding
12:00 Matt Schipper - University of Michigan
Individualized and Adaptive Selection of Radiation Dose via Utilities and Biomarkers
​
12:30 Lunch Location: Newcomb Hall - South Meeting Room
​
1:30 Monia Ezzalfani - Centre Léon Bérard, France
Novel Dose-Finding Design to Jointly Modeling Repeated Continuous Toxicity Score and Efficacy Data
2:00 Jun (Vivien) Yin - Mayo Clinic
An Adaptive Dose-finding Design Incorporating Continuous Efficacy and Toxicity Data from Multiple Treatment Cycles
2:30 Xavier Paoletti - Institut Gustave, Roussy, France
Optimal Benchmark Method Using Latent Variables for Evaluating Complex Designs in Early Phase Trials
​
3:00 Break
​
3:30 Thomas Braun - University of Michigan
Is There a Role for Randomization in Adaptive Dose-Finding?
4:00 Mourad Tighiourt - Cedars-Sinai Medical Center
Design of Phase I/II Drug Combination Cancer Trials Using CRM and Adaptive Randomization
4:30 Donglin Yan - University of Kentucky
Alternative Randomization Strategies for Seamless Phase I/II Adaptive Designs for Trials of Novel Cancer Treatments
5:15-6:15 Gina Petroni - University of Virginia
A General Discussion of Barriers to Implementing Novel Dose-finding Designs
​
Friday, April 28
Location of all events on Friday: Newcomb Hall - South Meeting Room
​
8:30 Cody Chiuzan - Columbia University
Sample Size Determination for the Two-stage Continual Reassessment Method
9:00 Tian Tian - AbbVie Inc. Pharmaceuticals
Optimal Design Theory in Early-Phase Dose-finding Designs
9:30 Alexia Iasonos - University of North Carolina at Chapel Hill
Semi-parametric Dose Finding Methods
​
10:00 Break
​
10:30 Yuan Ji - University of Chicago
A Bayesian Design for Dose Finding with Combination Therapies in Oncology
11:00 Liz Garrett-Mayer - Medical University of South Carolina
Novel Design Considerations for Immunotherapy and Targeted Agents in Oncology
11:30 Beth Horton - University of Virginia
Continual Reassessment Method for Partially Ordered Groups
​
​
​
​
​
Keynote Speaker
Steven Piantadosi
Phase One Foundation Distinguished Chair
Director, Samuel Oschin Cancer Institute
Professor of Medicine
Cedars-Sinai Medical Center
Steven Piantadosi, MD, PhD, is director of the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai. Dr. Piantadosi’s role is to lead the medical center’s programs in cancer research, treatment and education, enhance academic activities related to cancer and bring together Cedars-Sinai’s cancer physicians and researchers for innovative collaborations. Prior to joining Cedars-Sinai in April 2007, Dr. Piantadosi was Professor of Oncology at The Johns Hopkins University School of Medicine and Director of Biostatistics at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. He also was Professor of Biostatistics and Professor of Epidemiology at the university’s Bloomberg School of Public Health. After earning his medical degree from the University of North Carolina and doctorate in Biomathematics from the University of Alabama at Birmingham, Dr. Piantadosi became a senior staff fellow at the National Cancer Institute.
​
Dr. Piantadosi is one of the world’s leading experts in the design and analysis of clinical trials for cancer research. He has advised numerous academic programs and collaborations nationally regarding clinical trial design and conduct, and has served on external advisory boards for the National Institutes of Health and other prominent cancer programs and centers. The author of more than 260 peer-reviewed scientific articles, Dr. Piantadosi has published extensively on research results, clinical applications and trial methodology. While his papers have contributed to many diverse areas of oncology, he has also collaborated on studies in disciplines outside cancer including lung disease and degenerative neurological disease.
JRSS-C Special Issue
​
The Journal of the Royal Statistical Society - Series C (Applied Statistics) is inviting submissions for a special issue focusing on early phase clinical trial design methodology. Contributions to this special issue will include, but will not be limited to, suitable papers from presentations given at the symposium. For more details, please see the announcement from the journal.
There will be a conference fee of $150 to defray the costs of food, speaking rooms, audio/visual, etc. Upon receipt of registration and payment, you will receive an email confirmation and EPay receipt. Registration fees will be refunded (less a $50 administrative fee) for written email cancellations received a minimum of 14 days prior to the activity date. No refunds will be granted for registration fees of less than $50 or for cancellations made within 13 days of the activity.
​
The University of Virginia School of Medicine reserves the right to cancel activities if necessary. In this case, the entire registration fee will be refunded. All other expenses incurred in conjunction with this activity are the sole responsibility of the participant.
Newcomb Hall
180 McCormick Rd
Charlottesville, VA
Tel: 434-297-8728
Fax: 434-243-5787
