Rome Foundation meets with the US Food and Drug Administration
On Monday, December 3, 2007, representatives of the Rome Foundation traveled to the FDA to meet with members of the FDA Center for Drug Evaluation and Research (CDER) and Study Endpoints & Label Development (SEALD) groups of the FDA. The purpose of the meeting was to discuss the mission and efforts of the Rome Foundation to develop programs of mutual interest relating to clinical trials, address ongoing challenges relating to clinical endpoints in the field of functional gastrointestinal disorders, specifically irritable bowel syndrome (IBS) and the functional dyspepsia (FD) subcategories, postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS).
Areas of discussion included design of treatment trials, proper diagnosis and selection criteria for clinical trials in these disorders, currently used outcome measures and ongoing and planned activities by the Rome Foundation to gain better knowledge of appropriate endpoints and outcome measures and severity assessment.
The Rome Foundation began with a discussion of the history and mission of the Rome Foundation to legitimize and advance the field of FGIDs. In addition to the topics noted, the members also described the existing upcoming activities related to trial design, including the Rome Outcomes and Endpoints in IBS working team and the 2009 Rome Outcomes Conference.
The Rome Foundation hopes to continue the dialogue in an effort for collaboration to further promote research and investigation in the management, treatment, and quality of life of patients who suffer with FGIDs. The FDA has been invited and has agreed to send a representative to the 2009 Rome Outcomes Conference.