Derivan Albert T, Leventhal Bennett L, March John, Wolraich Mark, Zito Julie Magno
Pediatric Drug Development, Johnson & Johnson Pharmaceutical Research & Development, Philadelphia, PA, USA.
J Child Adolesc Psychopharmacol. 2004 Summer;14(2):169-74. doi: 10.1089/1044546041649057.
The authors reviewed various statements describing the ethical use of placebo-controls in clinical trials involving minors. Attention was focused upon the Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations, published by the American Academy of Pediatrics (AAP) (Kaufman et al. 1995). A brief review of certain key documents and a possible expansion of the guidelines are presented. Specifically, it is recommended that a review and update of guidelines for the use of placebo-controlled trials in children be undertaken by a working group comprised of stakeholders, including academic clinical and research professionals, bioethicists, consumers, members of key government agencies, and the pharmaceutical industry.
