OPT will conduct a study to identify and evaluate alternate endpoints which have and/or can be used in pediatric clinical trials. The Institute of Medicine (IOM) also will be conducting such an analysis using publicly available data as mandated by FDAAA 2007. OPT will evaluate this same question using all data available to FDA, focusing on products in one therapeutic area of importance to pediatrics (e.g., neurology, cardiovascular, or metabolic/endocrine). The results of this study will greatly enhance FDA's ability to identify critical improvements in the path for pediatric product development.OPT conducted a study to identify and evaluate alternate endpoints which have and/or could be used in pediatric clinical trials in collaboration with the Division of Gastroenterology and Inborn Error Products (DGIEP). An alternate endpoint was defined as a primary (or secondary) outcome specifically designed for the pediatric population and used to assess the impact of study treatment, where the endpoint was different from the one used in adult clinical trials. The primary objective was to evaluate the alternate endpoints and activity indices in the registration trials of the approved therapies for pediatric Ulcerative Colitis (UC). The results demonstrated that alternate endpoints were used as primary endpoints in the Colazal® pediatric trial and used as secondary endpoints for the Remicade® pediatric trial. There was also no consistency in the definition of primary efficacy endpoints and the instruments in pediatric UC registration trials. These results have been published as an abstract at the 2012 Pediatric Academic Societies (PAS) and at the 2012 North American Society for Pediatric Gastroenterology Hepatology, and Nutrition (NASPGHAN. The study has also been submitted to the Journal of Pediatric Gastroenterology and Nutrition (JPGN) for publication.A. Establish Task Order with the Institute of Medicine9/27/2010Completed9/1/2010B. Identify Area of Therapeutic Focus4/1/2011Completed4/15/2011C. Establish Working Group and Identify Tasks6/1/2011Completed5/31/2011D. Preliminary Analysis and Decision on Timeline10/1/2011Completed10/31/2011E. First Draft of Assessments/Recommendations12/31/2011Completed12/31/2011http://www.fda.gov/ScienceResearch/SpecialTopics/PediatricTherapeuticsResearch/ucm121586.htmPediatrics Publications: 2006-2012http://www.fda.gov/AboutFDA/Transparency/track/ucm206293.htmFDA-TRACK Office of Special Medical Programs Dashboard