Archives of General Psychiatry · 2002 · 41 citations · 15 references
MedicinePharmacologyPsychiatryClinical PharmacologyPsychopharmacologyRegulatory ScienceClinical TrialsDrug EvaluationEfficacy EvaluationInvestigational New Drug ApplicationsPharmacoepidemiologyRegulatory PharmacologyClinical Adverse EffectsClinical Pharmacology EvidenceClinical Protocol DesignOrganizational Assumptions
The major purpose of this American Society of Clinical Psychopharmacology-sponsored meeting was to identify strategies for more efficiently detecting clinical drug effects, thus reducing the economic and scientific risks of investigating new chemical entities in psychiatric disorders. The meeting consisted of presentations and discussions by experts who repeatedly had difficulty pursuing scientific, public health--relevant goals. Many approaches to improving the detection of potentially beneficial agents were reviewed. In this article, we discuss technically feasible study improvements. The scope of inquiry included identifying means of shifting institutional and regulatory assumptions and processes, even to the point of seeking appropriate national incentives.
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Gordon D. Schiff, T. Donald Rucker · JAMA · 1998 · 250 citations
Research and Development Costs for New Drugs by Therapeutic Category
Joseph A. DiMasi, Ronald W. Hansen, Henry G. Grabowski et al. · PharmacoEconomics · 1995 · 170 citations