Workshop Schedule
Schedule information is subject to change. Additional faculty details to be added as invitations are accepted. Last updated 15 October 2025.
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Tuesday, 19 May 2026 - High Level Review of Concepts
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| Time |
Session |
| 8:00 a.m. |
Course Introduction: Course Format and Expectations
Presented by Michael C. Soulen, MD, FSIR, FCIRSE
|
| 8:15 a.m. |
Anatomy of a Clinical Trial: Objectives, Outcome Measures, Hypotheses, and Common Pitfalls
Presented by Michael C. Soulen, MD, FSIR, FCIRSE
|
| 8:45 a.m. |
Review of Statistical Concepts
Presented by Nicholas J. Seewald, PhD
|
| 9:30 a.m. |
Phase I Trials: Clinical Objectives, Endpoints, 2-Stage Study Designs, Sample Size, Statistical Analyses
Presented by Mark H. O'Hara, MD
|
| 10:15 a.m. |
Break
|
| 10:45 a.m. |
Phase II Trials: Clinical Objectives, Endpoints, 2-Stage Study Designs, Sample Size, and Statistical Analyses
Presented by Gregory Nadolski, MD
|
| 11:30 a.m. |
Interventional Oncology Trials: Design Complexities and Pitfalls
Presented by Michael C. Soulen, MD, FSIR, FCIRSE
|
| 12:15 p.m. |
Lunch |
| 1:15 p.m. |
Protocol Development Group (PDG) Session |
| 4:45 p.m. |
Adjourn |
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Wednesday, 20 May 2026 - Clinical Trials
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| Time |
Session |
| 8:00 a.m. |
Phase III Trials: Clinical Objectives, Endpoints, Sample Size, Statistical Analyses
Presented by Amy S. Clark, MD, MSCE
|
| 8:45 a.m. |
Combination Therapy Trials: Image-Guided and Systemic
Presented by Neil K. Taunk, MD, MSCTS
|
| 9:30 a.m. |
STATS: Survival Analysis
Presented by Nicholas J. Seewald, PhD
|
| 10:00 a.m. |
Break
|
| 10:30 a.m. |
Cost Effectiveness Analysis
Presented by Resmi A. Charalel, MD, MPH
|
| 11:15 a.m. |
STATS: Study Designs, and Regression Modeling Analysis
|
| 12:00 p.m. |
Lunch |
| 1:00 p.m. |
Protocol Development Group (PDG) Session 2 |
| 4:00 p.m. |
Office Hours |
| 5:00 p.m. |
Adjourn |
|
Thursday, 21 May 2026 - Correlative Studies & Data Science for Clinical Research
|
| Time |
Session |
| 8:00 a.m. |
Correlative Studies: Imaging and Serum/Tissue Biomarkers, Predictive vs. Prognostic Biomarkers
Presented by Jorge A. Marrero, MD, MS
|
| 8:45 a.m. |
STATS: Propensity Scoring and Weighted Analyses
|
| 9:30 a.m. |
STATS: Study Designs and ROC Analysis
|
| 10:15 a.m. |
Break
|
| 10:45 a.m. |
Informatics and Large Databases: National Cancer Data Base, Registries, Digital/Electronic Health Records (eHR): Flatiron Health
|
| 11:15 a.m. |
Registries and Prospective Observational Multi-Procedure Studies
|
| 11:45 a.m. |
Clinical Trials of Deep Learning/AI |
| 12:15 p.m. |
AI Models and Tools for Clinical Trial Design, Planning, and Conduct
Presented by Qi Long, PhD
|
| 1:00 p.m. |
Lunch |
| 1:30 p.m. |
Protocol Development Group (PDG) Session 3 |
| 4:00 p.m. |
Office Hours |
| 5:00 p.m. |
Adjourn |
|
Friday, 22 May 2026
|
| Time |
Session |
| 8:00 a.m. |
Device Based Trials
Presented by Bruno C. Odisio, MD, PhD, FSIR, FCIRSE
|
| 8:45 a.m. |
Incorporating Quality of Life Assessment, Financial Toxicity, and Healthcare Utilization a Clinical Research Study
Presented by Resmi A. Charalel, MD, MPH
|
| 9:30 a.m. |
Compliance, Ethics, and Informed Consent
Presented by Vicki Sallee
|
| 10:15 a.m. |
Break
|
| 10:30 a.m. |
FDA Regulation of Devices
Presented by Vicki Sallée, PhD, MS, RD, RAC
|
| 11:15 a.m. |
GCP Compliance: Importance of Good Data (coordinators/CRAs), Regulatory Adherence
Presented by Vicki Sallée, PhD, MS, RD, RAC
|
| 12:30 p.m. |
Lunch |
| 1:30 p.m. |
Protocol Development Group (PDG) Session 4
|
| 1:00 p.m. |
Lunch |
| 4:00 p.m. |
Office Hours |
| 5:00 p.m. |
Adjourn |
|
Saturday, 23 May 2026 - Building the Right Team
|
| Time |
Session |
| 8:00 a.m. |
Navigation the National Clinical Trials Network
Presented by Michael C. Soulen, MD, FSIR, FCIRSE
|
| 8:30 a.m. |
How to be a Site for a Multi-Center Trial
Presented by Kathleen Thomas
|
| 9:00 a.m. |
How to Run a Multi-Center IIT: Site Selection, Startup, and Site Budgets
Presented by Suresh Vedantham, MD
|
| 9:30 a.m. |
Funding Partnerships: Industry, Cooperative Groups, Professional Societies
Presented by Terence P. Gade, MD, PhD
|
| 10:00 a.m. |
Break
|
| 10:30 a.m. |
How to Craft a Trial Budget and Smart Contracts
|
| 11:00 a.m. |
Barriers to Accrual and How to Overcome Them
Presented by Carmen E. Guerra, MD, MSCE, FACP
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