Clinical Trial Design and Alterations in Drug Disposition with Age
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CLINICAL TRIAL DESIGN AND ALTERATIONS IN DRUG DISPOSITION WITH AGE* MICHAELL. CHRISTENSEN, PHARMD Departments of Pediatrics and Clinical Pharmacy
RUSSELLW. CHESNEY,MD Department of Pediatrics
RICHARDA. HELMS,PHARMD Departments of Pediatrics and Clinical Pharmacy Pediatric Pharmacology Research Unit, Center for Pediatric Pharmacokinetics and Therapeutics, The University of Tennessee, Memphis, and Crippled Children’s Foundation Research Center, Le Bonheur Children’s Medical Center, Memphis, Tennessee
Most drugs lack information on their safe and effective use in children. This dilemma limits the number of potentially useful medications in children or places children at increased risk for therapeutic misadventures. A number of problems have hampered the study of drugs in children: childhood is a period of rapid physiologic change, children represent a small market share, drug development is costly, and there are ethical concerns of using children as research subjects. Enactment of the Food and Drug Administration (FDA) Modernization Act (FDAMA) and issuance of the Pediatric Studies regulations will have a dramatic impact on increasing the number of drugs approved for use in children. Important issues must be addressed regarding the design of clinical trials in children, including delineation of disease, use of suitable controls, when investigational drugs should be studied, and which pediatric age groups need to be studied. There is real optimism that the increased interest in obtaining pediatric labeling will lead to a greater number of drugs being approved for use in children. Key Words: Pediatrics: Clinical trial; FDA; Drug regulation; Drug formulation
drug development over the past 50 years. Most FDA-approved drugs lack approval for use in children or are restricted to certain pediatric age groups, predominately adolescents. Only a few of the new drugs approved Presented at the DIA 35th Annual Meeting, June 27each year have pediatric indications. The lack July 1, 1999, Baltimore., Maryland. of information on the safe and effective use Repint address: ~ ~w. Chesney, ~ ~Department l l of Pediatrics and Clinical Pharmacology. The Univer- of drugs in the most vulnerable patients, insity of Tennessee, 50 N. Dunlap St., Memphs. TN fants and neonates, is of greatest concern. 38103. There are a number of problems that have *Supported in part by a grant from PHS UO1 HDhampered clinical drug testing in children. 31326, by a Center of Excellence grant from The State Childhood is a p e r i d of rapid change in of Tennessee, and a grant from the Crippled Children’s many of the physiologic processes that govFoundation Research Center.
CHILDREN HAVE UNFORTUNATELY been excluded from some of the therapeutic advances that have marked pharmaceutical
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Michael L. Christensen, Russell W. Chesney, and Richard A. Helms
em drug disposition and effect. Consequently, studies
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