AACAP 2002 research forum: placebo and alternatives to placebo in randomized controlled trials in pediatric psychopharmacology.
OBJECTIVE
The use of placebo in the pediatric age group has come under increasing scrutiny. At the 2002 Annual Meeting of the American Academy of Child and Adolescent Psychiatry, the Academy's Workgroup on Research conducted a research forum. The purpose was to identify challenges and their solutions regarding the use of placebo in randomized controlled trials in pediatric psychopharmacology.


METHODS
Workgroups focused on problems and solutions in five areas: ethics and human subjects, research design and statistics, partnering with consumers, U.S. Food and Drug Administration and pharmaceutical industry perspectives, and psychosocial treatments.


RESULTS
In many but not all circumstances, inclusion of a placebo control is essential to meet the scientific goals of treatment outcome research. Innovative research designs; involvement of consumers in planning and implementing research; flexibility by industry, academia, the National Institutes of Health, and regulatory agencies acting in partnership; and concomitant use of evidence-based psychosocial services can and should assist in making placebo-controlled trials acceptable.


CONCLUSIONS
Properly designed placebo-controlled trials remain necessary, ethical, and feasible.
March
John
J
Duke University Medical Center, Durham, NC 27705, USA. jsmarch@acpub.duke.edu
Kratochvil
Christopher
C
Clarke
Gregory
G
Beardslee
William
W
Derivan
Albert
A
Emslie
Graham
G
Green
Evelyn P
EP
Heiligenstein
John
J
Hinshaw
Stephen
S
Hoagwood
Kimberly
K
Jensen
Peter
P
Lavori
Philip
P
Leonard
Henrietta
H
McNulty
James
J
Michaels
M Alex
MA
Mossholder
Andrew
A
Osher
Trina
T
Petti
Theodore
T
Prentice
Ernest
E
Vitiello
Benedetto
B
Wells
Karen
K
D000293:Adolescent; D000296:Adolescent Psychiatry; D002648:Child; D002665:Child Psychiatry; D004493:Education; D006801:Humans; D010919:Placebos / Q000627:therapeutic use*; D011619:Psychotropic Drugs / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012955:Societies, Medical; D014481:United States
D010919:Placebos; D011619:Psychotropic Drugs