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Drs. DeVeaugh-Geiss, March, Mangum, and Silva, and Mr. Shapiro are with Duke Clinical Research Institute, Durham, NC; Drs. Andreason, Murphy, and Roberts are with the U.S. Food and Drug Administration, Rockville, MD; Dr. Emslie is with the University of Texas Southwestern Medical Center, Dallas; Dr. Ford is with Johnson & Johnson, Titusville, NJ; Dr. Greenhill is with the New York State Psychiatric Institute, New York; Dr. Prentice is with the University of Nebraska Medical Center, Omaha; Dr. Swanson is with the University of California, Irvine; Dr. van Zwieten-Boot is with the Committee for Medicinal Products for Human Use Medicines Evaluation Board, The Hague, The Netherlands; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD; and Dr. Wagner is with the University of Texas Medical Branch, Galveston.
Published: March 2006
AI Article Synopsis
Article Abstract
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.
