The Pediatric Research Initiative in the United States: Implications for Global Pediatric Research

Abstract

Recognition of cultural and ethnic differences in target populations for drugs, an increase in multi-country new drug application submissions, harmonization of international regulatory requirements and research guidelines, and the availability of multinational contract research organizations (CROs) will facilitate the current trend toward increased multinational clinical research trials. Currently, approximately 20% of research by United States-based companies is already conducted outside the United States. Since new drug applications submitted to the United States Food & Drug Administration (FDA) will require pediatric studies for any drugs with potential use in the pediatric population, it is likely that they will be done by any drug sponsor planning to enter its product in the United States market at some point in the product's life cycle regardless of the country of origin. Although the current United States domestic market for pediatric drugs is considered small, nearly 20% of all drug sales in developed countries worldwide are for patients under 18 years of age. The pediatric drug market in developing countries may be just as important. It has been estimated that by the year 2000, developing countries, where more than half of the population are children, will comprise 36% of the world market for pharmaceuticals. Establishment of international standards for pediatric drug development, currently in process by the International Conference on Harmonization (ICH), should eventually result in availability of consistent formulations of needed therapeutic drugs for all children worldwide.