Child and adolescent psychopharmacology in the new millennium: a workshop for academia, industry, and government.

Published

Journal Article

OBJECTIVE: To give academic researchers, government officials, and industry scientists an opportunity to assess the state of pediatric psychopharmacology and identify challenges facing professionals in the field. METHOD: Increased federal spending and the introduction of pediatric exclusivity led to large increases in pediatric psychopharmacology research in the 1990s. Despite the increase in research, concerns exist about methods and incentives for making new medications available for use in pediatric psychiatric disorders. In recognition of these concerns, the Duke Clinical Research Institute held a roundtable in September 2004. Participants from the National Institutes of Health, regulatory agencies, academia, and the pharmaceutical industry spoke about the effects of government regulations such as the U.S. Food and Drug Administration Modernization Act and the Pediatric Research Equity Act on pediatric research from academic, clinical, and industry perspectives, and bioethical considerations of such research. CONCLUSIONS: To ensure development of new drugs for treating psychiatric disorders in children and adolescents, we must address the challenges posed by the regulatory environment governing pediatric psychopharmacology research. Strategies were identified for improving the evidence base for psychopharmacologic interventions in youth before widespread use and for more effectively defining a research agenda for the future.

Full Text

Duke Authors

Cited Authors

  • DeVeaugh-Geiss, J; March, J; Shapiro, M; Andreason, PJ; Emslie, G; Ford, LM; Greenhill, L; Murphy, D; Prentice, E; Roberts, R; Silva, S; Swanson, JM; van Zwieten-Boot, B; Vitiello, B; Wagner, KD; Mangum, B

Published Date

  • March 2006

Published In

Volume / Issue

  • 45 / 3

Start / End Page

  • 261 - 270

PubMed ID

  • 16540810

Pubmed Central ID

  • 16540810

Electronic International Standard Serial Number (EISSN)

  • 1527-5418

International Standard Serial Number (ISSN)

  • 0890-8567

Digital Object Identifier (DOI)

  • 10.1097/01.chi.0000194568.70912.ee

Language

  • eng