Impact of recent findings on study design of future autism clinical trials.
There are specific challenges to studying the design of pharmacologic trials in child/adolescent and adult autism, such as subject stratification and parallel versus crossover designs. This article describes how optimal study design is influenced by subject selection and outcome measures chosen. Lessons learned in study design from the Research Units on Pediatric Psychopharmacology Autism Network trial with risperidone, Seaver Center trials with fluoxetine and valproate, Dartmouth trials with amantadine, and National Institutes of Health secretin trials are highlighted. The Internet System for Assessing Autistic Children system for managing multicenter clinical trials in autism and statistical issues in autism research are also described.
Department of Psychiatry, Mount Sinai School of Medicine, New York City, New York 10029-6574, USA. eric.hollander@mssm.edu
Eric
E
Hollander
Ann
A
Phillips
Bryan H
BH
King
Donald
D
Guthrie
Michael G
MG
Aman
Paul
P
Law
Thomas
T
Owley
Ricki
R
Robinson
D000293:Adolescent; D001321:Autistic Disorder / Q000188:drug therapy*; D002648:Child; D002986:Clinical Trials as Topic; D006801:Humans; D015337:Multicenter Studies as Topic; D012107:Research Design