Meetings and Events
Endpoints and Outcomes Conference 2009:
Optimizing Clinical Trials in FGID
8:00 am-5:45 pm
Thursday, April 16, 2009
8:00 am-12:00 noon
Pfister Hotel
Milwaukee, Wisconsin, USA
Download program draft here
A major initiative by the Rome Foundation is to host a consensus conference in 2009 on outcomes and endpoints in functional GI disorders (FGIDs). This will be similar to the consensus conference held in Vienna in 1998. The meeting is scheduled for April 15-16, 2009, immediately before at the time of the 8th International Symposium on Functional Gastrointestinal Disorders hosted by the International Foundation for Functional Gastrointestinal Disorders (IFFGD) and the Joint International Neurogastroenterology meetings in Milwaukee, Wisconsin.
The planning committee includes Lin Chang, MD (Chair), E. Jan Irvine, MD, Douglas A. Drossman, MD, Nancy J. Norton, Robin Spiller, MD, William E. Whitehead, PhD, and Carlar Blackman. The planning committee anticipates that participants will include academia, the pharmaceutical industry, the FDA (and other interested regulatory agencies), and patient advocacy groups.
The conference will be held all day on Wednesday, April 15, 2009, and Thursday morning (until noon), April 16, 2009, in Milwaukee in conjunction with the IFFGD meeting. It will be an open meeting which will last 1½ days just prior to the scientific meeting.
The Outcomes Conference will include presentations on:
- • Clinical trial endpoints
- • Meaningful outcomes for patients
- • Risk-benefit assessment
- • Severity of FGID
- • Perspectives from Industry, Regulatory Agencies and NIH about Drug Regulation and Development in FGIDs
In addition, there will be brief lectures on the role of the measures below and how they might fit into clinical research in the FGIDs, after which moderated breakout groups will have further discussion. Summaries of each breakout session will be presented to the entire group.
- • Role of biomarkers
- • Psychological symptoms and co-morbidities
- • Health behaviors, economic outcomes, HRQOL
Representatives from regulatory agencies (FDA, EMEA, Japan Pharmaceutical and Medical Devices Agency) and the NIH are participating in the meeting. They will participate in presentations and the panel discussion (see above).
The Rome Foundation is preparing for this conference through a variety of initiatives. First is the ongoing systematic review and meta-analysis of large pharmaceutical clinical trials databases by the Outcomes/Endpoints in IBS committee chaired by Michael Camilleri, MD. A number of pharmaceutical companies are cooperating with the committee by agreeing to share patient-level data from their databases. Brennan Spiegel, MD and Roger Bolus, PhD, a biostatistician, are working on harmonizing and analyzing the data. In this regard, Foundation representatives will be contacting sponsors regarding our interest in obtaining new data for ROME IV to help us move the field forward.
Second, we are obtaining data regarding the issue of severity in functional GI disorders through our Severity Working team chaired by Douglas Drossman, MD. This involves several separate analyses focused on illness severity based on data obtained from patient focus groups, a large national database of patients diagnosed with IBS coordinated by Doug Drossman with Nancy Norton of the IFFGD, and the UCLA database of IBS patients coordinated by Brennan Spiegel and Lin Chang. This information will be compiled into a report and presented at the Outcomes meeting.
Information on registration for the meeting will be posted on the Rome Foundation website in Winter 2008. If you would like to be alerted when registration for the Endpoints and Outcomes Conference is available, please join our mailing list.
The Rome Foundation would like to thank our sponsors providing educational grants for the
conference:
Procter & Gamble Pharmaceuticals
Ironwood Pharmaceuticals, Inc.
Takeda Pharmaceuticals North America