Endpoints and Outcomes Conference 2009: Optimizing
Clinical Trials in FGID

Wednesday, April 15, 2009
8:00 – 8:05am Welcome Lin Chang
8:05 – 8:15am Historical Perspective, Rome Outcomes Conference, WCOG Vienna 1998 William Whitehead
8:15 – 8:30am Goals & aims of this conference Lin Chang

8:30 – 10:25am Clinical trial Endpoints
Moderator: Sander van Zanten
8:30 – 9:00am Results from the Rome Endpoints/Outcomes in IBS working team
Introduction: How did we get here? Michael Camilleri
Results from the Endpoints Analysis Brennan Spiegel
9:00 – 9:20am Outcome Measures for IBS Clinical Trials: Qualitative Interviews and Quantitative Assessment of PRO Items in a Phase 2b Linaclotide Study Jeffrey Johnston
9:20 – 9:40am How Well do the Rome III Guidelines for Trials Outcomes Measure Up? Jan Irvine
9:40 – 10:00am Feasibility of using responder definition based on primary Endpoint – The experience from Japan Kei Matsueda
10:00 – 10:30am Discussion Peter Tugwell

10:45 – 11:45am Meaningful outcomes for patients
Moderator: Doug Drossman
10:45 – 11:05am Translation of outcome measures to meaningful Endpoints Donald Patrick
11:05 – 11:25am Measures of clinical benefit
(MCID, MCII, etc)
Fasiha Kanwal
11:25 – 11:45am Discussion Brennan Spiegel

11:45 – 12:45pm Risk-benefit assessment
Moderator: Bill Whitehead
11:45 – 12:05pm Risk and medications in IBS patients Brian Lacy
12:05 – 12:25pm IFFGD survey of risk-benefit assessment Nancy Norton
12:25am-12:45pm Discussion Brennan Spiegel

1:45 – 2:45pm Panel discussion: Perspectives from Industry, Regulatory Agencies and NIH about Drug Regulation and Development in FGIDs
Moderator: B. Chey
1:45 – 1:55pm Perceptions of industry on drug regulation Charles Baum
1:55 – 2:05pm Perspective of US regulatory agencies on drug development Ann Marie Trentacosti
2:05 – 2:15pm Proposed Interim Endpoints for IBS clinical trials Ruyi He
2:15 – 2:25pm Perspective of EU regulatory agencies on drug development Sif Ormarsdóttir
2:25 – 2:45pm Discussion

2:45 – 3:35pm Severity of FGID
Moderator: Peter Whorwell
2:45 – 3:15pm Update on severity assessment
(Rome working team, severity focus group, FBDSI, IBS-SS)
Douglas Drossman
3:15pm-3:25pm Discussion Fermín Mearin

3:45pm-6:30pm Breakout sessions on other outcome measures
Moderator: Magnus Simren
3:45 – 4:05pm Role of biomarkers Robin Spiller
4:05 – 4:20pm Psychological symptoms and co-morbidities Bruce Naliboff
4:20 – 4:35pm Health behaviors, economic outcomes, HRQOL Brennan Spiegel
4:35 – 4:50pm Clinical Endpoints for gastroparesis Henry Parkman
5:00 – 6:30pm Breakout groups
(4 simultaneous sessions)
1. Biomarkers
Motility & Transit
Visceral sensitivity measurement
Mucosal inflammation
Cytokines, Microbiota
Genetic polymorphisms
John Kellow
Jan Tack
Giovanni Barbara
Eamonn Quigley
Nicholas Talley
2. Psychological symptoms and co-morbidities Naliboff/Sperber/Lydiard
3. Health behaviors, economic outcomes, HRQOL
Health-Related Quality of Life Handout
Outcome Measures in Irritable Bowel Syndrome
Health Behaviors, Economic Outcomes, and Health Related Quality of Life
A Checklist for Evaluating Scales

Brennan Spiegel

C. J. Bijkerk

Brennan Spiegel
David L. Streiner

4. Clinical Endpoints for Gastroparesis
Relationship of Gastric Function and Symptoms. A Role for Gastroparesis Tests in Endpoints
GCSI and PAGI-SYM: Development and Recent Studies
Other Clinical Trial Endpoints for Gastroparesis
Assessing Severity of Gastroparesis: Quality of Life, Gastric Emptying, Other measures

Michael Camilleri

Dennis Revicki

Richard McCallum

Bill Hasler

Thursday, April 15, 2009
8:00 – 10:00am Presentations of breakout group discussion
Moderator: Jan Irvine
8:00 – 8:15am Biomarkers Robin Spiller
8:30 – 8:45am Psychological symptoms and co-morbidities Bruce Naliboff
9:00 – 9:15am Health behaviors, economic outcomes, HRQOL Brennan Spiegel
9:30 – 9:45am Clinical Endpoints for gastroparesis Henry Parkman

10:30 – 11:30am Endpoints and outcome measures in Pediatric FGIDs
Moderator: Carlo Di Lorenzo
Summary
10:30 – 10:45am The urgent need for pediatric Endpoints: The scope of the problem Jan Taminiau
10:45 – 11:00am What do we know about pediatrics and how do we go about developing pediatric Endpoints in FGID? Sam Nurko

11:30 – 1:00pm Discussion of Outcomes Development project
Moderator: Lin Chang
11:30 – 12:00pm Patient Reported Outcomes Consortium: Proposed IBS Working Group
Framework for a Public-Private Partnership