Hostname: page-component-78c5997874-j824f Total loading time: 0 Render date: 2024-11-17T04:32:28.937Z Has data issue: false hasContentIssue false
  • English
  • Français

Government Initiatives in Autism Clinical Trials

Published online by Cambridge University Press:  07 November 2014

Benedetto Vitiello  and
Ann Wagner
Get access Rights & Permissions [Opens in a new window]

Abstract

Randomized clinical trials remain the most valid method of testing the efficacy and safety of treatments. While efforts to elucidate the genetic and neurodevelopmental bases of autism are underway, clinicians and families are in need of scientifically valid information on how to best treat patients with autism. The effectiveness of many interventions currently used in communities has not been adequately tested. Given the high public health relevance of autism treatment research and the low interest of the pharmaceutical industry in autism, the role of the National Institutes of Health in supporting this research is paramount. Among recently launched initiatives in autism clinical trials, there are the Research Units on Pediatric Psychopharmacology Autism Network and the network of centers for Studies to Advance Autism Research and Treatment. These and other government activities in the area of autism clinical trials are here briefly reviewed.

Type
Review Article
Information
CNS Spectrums , Volume 9 , Issue 1 , January 2004 , pp. 66 - 70
Copyright
Copyright © Cambridge University Press 2004

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1.Children's Health Act. Pub L No. §106-310 (2000).Google Scholar
2.McDougle, C, Scahill, L, Mc Cracken, JT, et al.Research Units on Pediatric Psychopharmacology (RUPP) Autism Network. Background and rationale for an initial controlled study of risperidone. Child Adolesc Psychiatr Clin N Am. 2000;9:201–224.CrossRefGoogle ScholarPubMed
3.RUPP Autism Network. Risperidone in children with autism and serious behavioral problems. N Engl J Med. 2002;347:314–321.CrossRefGoogle Scholar
4.RUPP Autism Network. Methylphenidate in Children and Adolescents with Pervasive Developmental Disorders. ClinicalTrials.Gov Web site. Available at: http://www.clinicaltrials.gov/ct/gui/c/a1r/show/NCT00025779?order=lJServSessionIdzone_ct=o6dpjvweq1. Accessed May 9, 2003.Google Scholar
5.National Institute of Mental Health. Research Units on Pediatric Psychopharmacology and Psychosocial Interventions (RUPP-PI). Request for Applications MH-02-002. NIH Guide; August 31, 2001.Google Scholar
6.Sandler, AD, Sutton, KA, DeWeese, J, Girardi, MA, Sheppard, V, Bodfish, JW. Lack of benefit of a single dose of synthetic human secretin in the treatment of autism and pervasive developmental disorder. N Engl J Med. 1999;341:1801–1806.CrossRefGoogle ScholarPubMed
7.National Institutes of Health. Autism Research Centers of Excellence: the STAART Program. Request for Applications MH-03-005. NIH Guide; March 6, 2002.Google Scholar
8.Rumsey, JM, Vitiello, B, eds. Treatments for people with autism and other pervasive developmental disorders: research perspectives [special issue]. J Autism Dev Disord. 2000;30:369–508.CrossRefGoogle Scholar
9.National Institute of Mental Health. Research workshop “Research on Psychosocial and Behavioral Interventions in Autism: Confronting Methodological Challenges.” September 5-6, 2002; Rockville, Md.Google Scholar
10.National Institute of Mental Health. Research workshop “Mental Health Aspects of Fragile X Syndrome: Treatment Research Perspectives.” November 16–17, 2001; Rockville, Md.Google Scholar
11. U.S. Food and Drug Administration Web site. The Orphan Drug Act. Available at: http://www.fda.gov/orphan/oda.htm. Accessed May 8, 2003.Google Scholar
12. FDA/Office of Orphan Products Development page. Food and Drug Administration Web site. Available at http://www.fda.gov/orphan/. Accessed May 9, 2003Google Scholar
13.Fombonne, E. The prevalence of autism. JAMA. 2003;289:87–89.CrossRefGoogle ScholarPubMed
14. U.S. Congress. Food and Drug Administration Modernization Act. Pub L No. 105-115, 1997.Google Scholar
15. U.S. Congress. Best Pharmaceuticals for Children Act. Pub L No. 107-109, 2002.Google Scholar