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 | |
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| 8:30 – 10:25am | Clinical trial Endpoints Moderator: Sander van Zanten |
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| 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 | |
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| 10:45 – 11:45am | Meaningful outcomes for patients Moderator: Doug Drossman |
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| 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 | |
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| 11:45 – 12:45pm | Risk-benefit assessment Moderator: Bill Whitehead |
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| 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 | |
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| 1:45 – 2:45pm | Panel discussion: Perspectives from Industry, Regulatory Agencies and NIH about Drug Regulation and Development in FGIDs Moderator: B. Chey |
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| 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 | ||
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| 2:45 – 3:35pm | Severity of FGID Moderator: Peter Whorwell |
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| 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 | |
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| 3:45pm-6:30pm | Breakout sessions on other outcome measures Moderator: Magnus Simren |
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| 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) |
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| 1. Biomarkers • Motility & Transit • Visceral sensitivity measurement • Mucosal inflammation • Cytokines, Microbiota • Genetic polymorphisms |
John Kellow Jan Tack Giovanni Barbara Eamonn Quigley Nicholas Talley |
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| 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 |
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| 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 |
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| 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 | |
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| 10:30 – 11:30am | Endpoints and outcome measures in Pediatric FGIDs Moderator: Carlo Di Lorenzo Summary |
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| 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 | |
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| 11:30 – 1:00pm | Discussion of Outcomes Development project Moderator: Lin Chang |
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| 11:30 – 12:00pm | Patient Reported Outcomes Consortium: Proposed IBS Working Group Framework for a Public-Private Partnership |