Evaluate the use of Extrapolation of Efficacy in Pediatric Trials in products submitted in response to the WRs issued by FDA. OPT will summarize its experience with the use of extrapolation of efficacy. An analysis of the level of evidence and historical changes in approach will be discussed by the involved divisions. A draft paper describing the approach to pediatric extrapolation will be provided for further input. A final paper will be developed for publication.OPT evaluated the use of extrapolation of efficacy in pediatric trials in products submitted in response to the Written Requests (WRs) issued by FDA. A final paper was developed for publication describing the approach to pediatric extrapolation. Extrapolation is important because it minimizes the number of pediatric patients needed to demonstrate safety and efficacy, and may expedite drug development. In this regard, extrapolation of efficacy from the adult to the pediatric population has helped to maximize the use of existing information to increase the efficiency of pediatric drug development programs while maintaining the goals of increasing the number of safe and effective medicines approved for pediatric use based on scientifically robust data. Over the last decade, FDA has tested its assumptions about extrapolation and modified its approaches as knowledge and experience increased. The approaches ranged along a continuum and are still being refined. The data we published in Pediatrics on 166 products submitted in response to 159 Written Requests submitted to the Agency between 1998 and 2008 should lead to a more informed use of extrapolation of efficacy in pediatric drug development programs for those involved in pediatric trial design as well as for health professionals. <p>Extrapolation of Adult Data and Other Data in Pediatric Drug-Development Programs Pediatrics 2011;128;e1242; originally published online October 24, 2011; Julia Dunne, William J. Rodriguez, M. Dianne Murphy, B. Nhi Beasley, Gilbert J.Burckart, Jane D. Filie, Linda L. Lewis, Hari C. Sachs, Philip H. Sheridan, Peter Starke and Lynne P. Yao DOI: 10.1542/peds.2010-3487</p> <p>The online version of this article, along with updated information and services, is located on the World Wide Web at: http://pediatrics.aappublications.org/content/128/5/e1242.full.html</p>A. Prepare and distribute draft paper for consideration by the Divisions which participated in the working group3/3/2010Completed3/3/2010B. Incorporate changes and have working group provide final review8/1/2010Completed5/27/2010C. Obtain internal clearance for submission to a peer reviewed journal11/5/2010Completed6/2/2010D. Manuscript developed for publication2/1/2011Completed5/16/2011http://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