Agenda: Day Two

Saturday, January 14th 2017

BREAKOUT 1

How to Plan and Start a Clinical Trial
Chair: Peter Higgins

8:00am–8:30am

Funding and Grantsmanship in Clinical Research
Peter Higgins

8:30am–8:45am

How (and Why) to Get Started: Community Gastroenterologist Perspective
Jon Hanson

8:45am–9:00am

How (and Why) to Get Started: Academic Perspective
Jim Lewis

9:00am–9:10am

Q & A

 

BREAKOUT 2

Organizational Strategies for Clinical Trials
Chair: Alandra Weaver

8:00am–8:15am

SOPs: What Are They, and Why Do We Need Them?
Susan Jackson (UNC)

8:15am–8:30am

Research Personnel and Research Space: A Place for Everything
Kay Sauder, Michigan

8:30am–9:00am

Recruitment, Retention and Monitoring of Study Subjects
Barbara Schliebe and Susan Jackson

9:00am–9:10am

Q & A

MAIN SESSION

Measurement of Outcomes in IBD Clinical Trials
Chairs: Hans Herfarth, Ray Cross

9:15am–9:35am

Activity and Endoscopic Measures: Crohn’s Disease
Jean-Fred Colombel

9:35am–9:55am

Activity and Biomarker Measures: Ulcerative Colitis
Mark Osterman

9:55am–10:05am

Q & A

10:05am–10:30am

Refreshment Break

10:30am–10:50am

Patient Reported Outcomes in IBD
Peter Higgins

10:50am–11:10am

Controversies in Patient Populations, Phenotyping
Miguel Regueiro

11:10am–11:30am

Children in IBD Studies: Critical Design Issues, Activity Measures and Markers
Jeffrey Hyams

11:30am–11:45am 

How Patients Feel about the Endpoints
Sara Ringer

11:45am–12:05pm

Factors affecting Clinical Trial Interest and Enrollment in IBD Patients
Alandra Weaver

12:05pm–12:20pm

Q & A

12:20pm–1:45pm

Lunch



SESSION 4

Challenges, Pitfalls and the Future of IBD Trials
Chairs: Balfour Sartor, Jean-Fred Colombel

1:45pm–2:05pm

Challenges and Pitfalls in Clinical Trials: Lessons Learned
Brian Feagan

2:05pm–2:25pm

Challenges in Investigator-Initiated Clinical Trials: Lessons Learned
Jim Lewis and Hans Herfarth

2:25pm–2:30pm

Q & A

2:30pm–2:50pm

The Future (Near and Far) of IBD Therapeutic Research
Balfour Sartor and Jean-Fred Colombel

2:50pm– 3:00pm

Closing Remarks