Science & Research
The Office of Pediatric Therapeutics is engaged in international collaborative exchanges. The objective of these exchanges is to ensure that pediatric studies are conducted in a scientifically rigorous and ethical manner and that pediatric patients are not exposed to unnecessary (e.g., duplicative) trials.
Distribution of Pediatric Patients in Studies Submitted to FDA (2002-2007), by Country
Pediatric legislation in the U.S. and Europe is driving pediatric product development on a global scale. In August 2007, EMA and FDA established monthly teleconferences to discuss product-specific pediatric development and topics related to product classes under the terms of Confidentiality Agreement. The objective of these exchanges are to enhance the science of pediatric trials and to avoid exposing children to unnecessary trials. This collaboration provides a robust ethical and scientific framework for pediatric studies.
Japan's PMDA joined these teleconferences in November 2009 and Health Canada in September 2010 as observers. They are now active participants in these monthly exchanges.
The monthly discussions include ethical, safety, and pediatric study feasibility issues as well as protocol discussions. The type of information exchanged includes: Pediatric Investigation Plans (PIPs); Written Requests; Pediatric Committee (PDCO) discussions; waivers and deferrals; choice of comparator and efficacy endpoints; status of ongoing pediatric studies; results of pediatric studies; safety concerns, including clinical holds; and plans for long-term safety monitoring.
FDA and EMA exchanged information on a total of 329 products and held 64 discussions on general topics (not product specific) from August 2007 through September 2013.
The purpose of FDA’s new pediatric Latin America program is to build, under our Confidentiality Commitment process, an ongoing mutually beneficial and constructive collaborative exchange of scientific information with regulators pertaining to pediatric clinical trials and product development. By exchanging information in a collaborative manner, we anticipate the development of a consortium of Latin American regulators.
Latin America is a major and growing geographical region for the conduct of pediatric pharmaceutical and medical device clinical trials. In 2011, OPT expanded their international program to include collaboration with regulatory agencies in Latin America. This new initiative has begun, in part, due to FDA’s ongoing successful exchanges with colleagues in Europe, as well as Latin America’s increasing role in pediatric medical product development . As a result, FDA receives data generated from pediatric clinical trials conducted in Latin America. Findings concerning the studies are documented in the following three publications authored by FDA’s Office of Pediatric Therapeutics.
- The Globalization of Pediatric Clinical Trials. Pediatrics 2012
- The Globalization of Pediatric Trials: Should We Be Worried? Pediatrics 2011
- Globalization Facilitates Pediatric Drug Development in the 21st Century. Drug Information Journal, 2010