Pediatric Drug Development: The International Conference on Harmonization Focus on Clinical Investigations in Children
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Drug I n f c m t i o n Journal, Vol. 34, pp. 809-819, Z o o 0 Prinfed in the USA. All rights reserved.
PEDIATRIC DRUG DEVELOPMENT: THE INTERNATIONAL CONFERENCE ON HARMONIZATION FOCUS ON CLINICAL INVESTIGATIONS IN CHILDREN M. RENBE SIMAR,PHD Clinical Operations, PPD Development, Austin, Texas
Recent public awareness and scientific advances have launched a reversal in the historical trend to virtually ignore the importance of obtaining reliable data from pediatric patients during the process of drug development. The need for well-designed clinical trials in children is now clearly recognized, and a few regulatory bodies have addressed the requirements for the conduct of these trials. Global consensus on the unique issues related to pediatric trials, howevec has been lacking. The International Conference on Harmonization recently released a draft of its guideline, “Clinical Investigation of Medicinal Products in the Pediatric Population. The objective of this paper is to discuss critical issues addressed by the guideline. It begins with a brief overview on the underlying need for the guideline and factors that have contributed to shifting attitudes toward the conduct ofpediatric clinical trials. Thefive major considerations outlined in the guideline are then summarized. The discussion for each of the key areas is supplemented with background information, representative cases, and points for further consideration. Key Words: Pediatric; Global; Guideline; Drug development
INTRODUCTION RECENT INITIATIVES IN THE development of pediatric medications are the result of long-standing concerns raised by pediatricians, clinical pharmacologists, and other experts on the ethical necessity for well-designed clinical trials in children. The International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use has recently directed efforts toward the global development of safe and effective therapeutic drugs for children. The overarching goal of the harmonization process is to enhance effi-
Reprint address: M. Renke Simar, PhD, Cerveau Consulting, 6409 La Carman Lane, Austin, TX 78749.
cient and cost-effective drug development by establishing international uniformity in the requirements for data to support the registration of medicinal products (1). In September 1998 an ICH Expert Working Group initiated development of a document on issues related to the conduct of pediatric clinical trials. This process has recently yielded a draft consensus guideline, “Clinical Investigation of Medicinal Products in the Pediatric Population” (ICH-Ell) (2). The objective of the ICH-Ell guideline is to provide rational approaches for the design and conduct of pediatric clinical trials. The intent is to increase the reliability of data in support of medications for children, thereby facilitating international pediatric drug development. The guideline encourages drug testing in children by addressing the unique considera-
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