RADIOLOGICAL SOCIETY OF NORTH AMERICA
2023 CLINICAL TRIALS METHODOLOGY WORKSHOP
Marriott Resort
Coronado, California
January 7 - 13, 2023
Day 1: Saturday, January 7, 2023
1:00 – 2:30 PM	Registration			Ballroom Foyer
2:45 – 3:45 PM	Pre-Test			Ballroom C
3:00 – 4:00 PM	Faculty Meeting			Coronado 7
4:15 – 6:30 PM	Protocol Development Group (PDG) Meetings
	Protocol Group 1		Schnall	Coronado 7
	Protocol Group 2		Thomas	Coronado 2
	Protocol Group 3		Lee, J	Coronado 3
	Protocol Group 4		Lee, S	Coronado 4
	Protocol Group 5		Carlos	Coronado 5
6:45 – 7:45 PM	Welcome Remarks and Dinner with Faculty			Ballroom AB
	Michael Soulen, MD
	Jeffrey Blume, PhD
7:45 – 8:15 PM	Workshop Overview			Ballroom AB
	Michael Soulen, MD
Day 2: Sunday, January 8, 2023 Daily Moderator: Jeffrey Blume, PhD
7:00 – 8:00 AM	Breakfast			Ballroom Foyer
7:00 – 8:00 AM	Faculty Meeting			Coronado 7
Session I:
8:00 – 8:30 AM	Taxonomy of Imaging Trials			Ballroom AB
	Patrick Bossuyt, PhD
8:30 – 9:15 AM	Principles of Assessing Diagnostic Imaging Tests			Ballroom AB
	Jeffrey Jarvik, MD , MPH
9:15 – 10:00 AM	Review of Statistical Concepts for Radiology			Ballroom AB
	Jeffrey Blume, PhD
10:00 – 10:20 AM	Break			Ballroom Foyer
Session II:
10:20 – 11:05 AM	Basics of Therapeutic Clinical Trial Design			Ballroom AB
	James Spies, MD, MPH
11:05 – 11:40 AM	Developing a Therapeutic Trial Protocol			Ballroom AB
	Anthony Shields, MD
11:40 AM – 12:25 PM	Principles of Radiology Study Design Chaya Moskowitz, PhD			Ballroom AB
12:30 – 3:30 PM	Working Lunch/ PDG Meetings
	Protocol Group 1		Schnall	Coronado 7
	Protocol Group 2		Thomas	Coronado 2
	Protocol Group 3		Lee, J	Coronado 3
	Protocol Group 4		Lee, S	Coronado 4
	Protocol Group 5		Carlos	Coronado 5
3:30 – 7:00 PM	Unstructured Time for Concept Development
7:00 PM	Student Protocol Concept Forms Due
	Dinner on your own
	Faculty Reviews Concept Forms
Day 3: Monday, January 9, 2023 Daily Moderator: Michael Soulen, MD
7:00 – 8:00 AM	Breakfast			Ballroom Foyer
7:00 – 8:00 AM	Faculty Meeting			Coronado 7
Session III:
8:00 – 8:50 AM	Outcomes Studies			Ballroom AB
	Patrick Bossuyt, PhD
8:50 – 9:20 AM	Introduction to ROC Analysis			Ballroom AB
	Andriy Bandos, PhD
9:20 – 10:00 AM	Recognizing and Controlling Bias			Ballroom AB
	Nancy Obuchowski, PhD
10:00 – 10:20 AM	Break			Ballroom Foyer
Session IV:
10:20 – 11:05 AM	Statistical Modeling			Ballroom AB
	Todd Alonzo, PhD
11:05 – 11:50 AM	Outcome Measures for Image-Guided Intervention Trials			Ballroom AB
	Michael C. Soulen, MD
11:50 – 12:10 PM	National Library Medicine (NLM) and NIH online tools for Researchers			Ballroom AB
	J. Jeffrey Carr, MD
12:10 – 2:45 PM	Working Lunch/PDG Groups
	Protocol Group 1		Schnall	Coronado 7
	Protocol Group 2		Thomas	Coronado 2
	Protocol Group 3		Lee, J	Coronado 3
	Protocol Group 4		Lee, S	Coronado 4
	Protocol Group 5		Carlos	Coronado 5
2:45 – 3:00 PM	Break
3:00 – 5:30 PM	One-on-one appointments with Faculty
6:30 – 8:00 PM	Buffet Dinner (Student and Faculty)			ALBACA Restaurant
Day 4: Tuesday, January 10, 2023 Daily Moderator: Chaya Moskowitz, PhD
7:15 – 8:00 AM	Breakfast			Ballroom Foyer
7:15 – 8:00 AM	Faculty Meeting			Coronado 7
Session V:
7:45 – 8:15 AM	Breakfast Panel: Working with a Statistician			Ballroom AB
	Chaya Moskowitz, PhD / Jeffrey Blume, PhD
8:15 – 9:05 AM	Survival Analysis / Assessing New Quantitative Imaging Biomarkers			Ballroom AB
	Chaya Moskowitz, PhD
9:05 – 9:35 AM	Imaging as a Predictor of Therapeutic Response			Ballroom AB
	Dan Pryma, MD
9:35 – 9:50 AM	Break			Ballroom Foyer
Session VI:
9:50 – 10:30 AM	Sample Size Considerations			Ballroom AB
	Todd Alonzo, PhD
10:30 – 11:00 AM	Informatics and Databases for Clinical Trial Protocols			Ballroom AB
	Anthony Shields, MD
11:00 – 11:30 AM	Protocol Development and Quality Assurance Issues in Imaging in Trials			Ballroom AB
	Susanna Lee, MD, PhD
11:30 – 11:50 AM	Group Photos			TBD
11:50 – 2:30 PM	Working Lunch/PDG Groups
	Protocol Group 1		Schnall	Coronado 7
	Protocol Group 2		Thomas	Coronado 2
	Protocol Group 3		Lee, J	Coronado 3
	Protocol Group 4		Lee, S	Coronado 4
	Protocol Group 5		Carlos	Coronado 5
2:30 – 2:45 PM	Break
2:45 – 4:45 PM	One-on-one Appointments with Faculty
7:00 PM	Student: Drafts of Protocols Due
	Faculty: Review protocols
	Dinner on your own
Day 5: Wednesday, January 11, 2023 Daily Moderator: Janie Lee, MD
7:00 – 8:00 AM	Breakfast			Ballroom Foyer
7:30 – 8:15 AM	Breakfast Panel: Machine Learning, AI, and Prediction			Ballroom AB
Blume, Lee, Bossuyt
Session VII:
8:15 – 9:00 AM	Introduction to Cost Effective Analysis			Ballroom AB
	Janie Lee, MD
9:00 – 9:30 AM	Novel Multilevel Outcomes in Imaging Research			Ballroom AB
	Ruth Carlos, MD, MS
9:30 – 9:50 AM	Break			Ballroom Foyer
Session VIII:
9:50 – 10:30 AM	Multi-reader, Multi-modality Studies			Ballroom AB
	Jeffrey Blume, PhD
10:30 – 11:00 AM	Methodologic Overview of Screening Studies			Ballroom AB
	Janie Lee, MD
11:00 AM – 11:40 AM	Regulatory, Compliance, Ethics and Informed Consent			Ballroom AB
	Kindra Cooper, JD, MPA, MA, CIP
11:45– 2:30 PM	Working Lunch/PDG Group
	Protocol Group 1		Schnall	Coronado 7
	Protocol Group 2		Thomas	Coronado 2
	Protocol Group 3		Lee, J	Coronado 3
	Protocol Group 4		Lee, S	Coronado 4
	Protocol Group 5		Carlos	Coronado 5
3:30 – 4:30 PM	Stats One-on-One
4:30 – 6:00 PM	Unstructured Time for Protocol Development
7:00 PM	Students: REVISED PROTOCOLS/IRB SECTION DUE
	Faculty: Identify problems for discussion
Day 6: Thursday, January 12, 2023 Daily Moderator: Michael Soulen, MD
7:00 – 8:00 AM	Breakfast			Ballroom Foyer
Session IX:
8:00 – 8:45 AM	Pragmatic Clinical Trials			Ballroom AB
	Jerry Jarvik, MD, MPH
8:45 – 9:20 AM	Sponsorship Economics and Practicalities of Running a Clinical Trial			Ballroom AB
	Mitch Schnall, MD, PhD
9:20 – 9:50 AM	FDA Regulation of Imaging Modalities			Ballroom AB
	Kindra Cooper, JD, MPA, MA, CIP
10:00 –10:20 AM	Break			Ballroom Foyer
Session X:	Career Development			Ballroom AB
10:20 – 10:35 AM	How to obtain a mentorship letter and what it should look like
	Charles Thomas, MD
10:35 – 10:50 AM	Finding the right mentoring relationship
	Susanna Lee, MD, PhD
11:30 – 12:00 PM	Strategies for Success
	Michael Soulen, MD
11:30 AM – 12:00 PM	Question and Answer Session with Panel			Ballroom AB
	Moderator: Panelists:	Michael Soulen, MD Jarvik, S. Lee, Schnall
12:00 – 1:15 PM	Post-test and Students Lunch			Ballroom AB
12:00 – 1:15 PM	Faculty Meeting with Lunch
1:30 – 3:30 PM	PDG Meetings
	Protocol Group 1		Schnall	Coronado 7
	Protocol Group 2		Thomas	Coronado 2
	Protocol Group 3		Lee, J	Coronado 3
	Protocol Group 4		Lee, S	Coronado 4
	Protocol Group 5		Carlos	Coronado 5
1:00 – 5:30 PM	Poster boards available for poster set-up			Ballroom AB
6:00 – 7:00 PM	Reception and Poster Session			Ballroom Foyer
7:00 – 9:00 PM	Closing Dinner (Faculty and Students)			Ballroom AB
Day 7: Friday, January 13, 2023
	Completed protocols due by electronic transmission to DOR@rsna.org