Impact of recent findings on study design of future autism clinical trials.

Abstract

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.

• Authors: Eric Hollander, Ann Phillips, Bryan H King, Donald Guthrie, Michael G Aman, Paul Law, Thomas Owley, Ricki Robinson
• Journal: CNS spectrums (CNS Spectr) Vol. 9 Issue 1 Pg. 49-56 (Jan 2004) ISSN: 1092-8529 [Print] United States
• PMID: 14999175 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S., Review)

Topics

• Adolescent
• Autistic Disorder (drug therapy)
• Child
• Clinical Trials as Topic
• Humans
• Multicenter Studies as Topic
• Research Design