Pediatrics Research Today is a free monthly online journal that collates and summarizes the latest research about Pediatrics, including details on child development, perinatal medicine, child health care.

Considerations in the rational design and conduct of phase I/II pediatric clinical trials: avoiding the problems and pitfalls.

Abdel-Rahman SM, Reed MD, Wells TG, Kearns GL

Division of Pediatric Clinical Pharmacology and Medical Toxicology, The Children's Mercy Hospitals and Clinics, Kansas City, Missouri, USA. srahman@cmh.edu

Over the past decade, there has been a heightened awareness of the need to include children in the drug development process. With this awareness has come an expansion of the infrastructure for conducting studies in children and an increase in the sponsorship of pediatric clinical trials. However, the growth in pediatric research has, in many cases, not been accompanied by an increase in the involvement of trained pediatric investigators when it comes to trial design and/or interpretation. Pediatric phase I/II protocols continue to span a spectrum from those that are carefully constructed to those that are poorly designed. This paper highlights the basic elements of phase I/II protocols that merit unique consideration when the clinical trial involves children. Illustrations are provided from our experience, which highlight problems that may arise when trials are not designed with the pediatric patient in mind.

Published 21 March 2007 in Clin Pharmacol Ther, 81(4): 483-94.
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