The ethical use of placebo in clinical trials involving children.
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.
Derivan
Albert T
AT
Pediatric Drug Development, Johnson & Johnson Pharmaceutical Research & Development, Philadelphia, PA, USA. doc@derivan.org
Leventhal
Bennett L
BL
March
John
J
Wolraich
Mark
M
Zito
Julie Magno
JM
D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics*; D017408:Guidelines as Topic; D006801:Humans; D010919:Placebos; D011600:Psychopharmacology / Q000941:ethics*; D016032:Randomized Controlled Trials as Topic / Q000941:ethics
D010919:Placebos