Methodological issues associated with preclinical drug development and increased placebo effects in schizophrenia clinical trials

Matt A. Brown, Ram J. Bishnoi, Sara Dholakia, Dawn I. Velligan

Research output: Contribution to journalReview article

Abstract

Recent failures to detect efficacy in clinical trials investigating pharmacological treatments for schizophrenia raise concerns regarding the potential contribution of methodological shortcomings to this research. This review provides an examination of two key methodological issues currently suspected of playing a role in hampering schizophrenia drug development; 1) limitations on the translational utility of preclinical development models, and 2) methodological challenges posed by increased placebo effects. Recommendations for strategies to address these methodological issues are addressed.

Original languageEnglish (US)
Pages (from-to)591-604
Number of pages14
JournalExpert Review of Clinical Pharmacology
Volume9
Issue number4
DOIs
StatePublished - Apr 2 2016
Externally publishedYes

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Keywords

  • clinical trials
  • drug development
  • methodological issues
  • pharmacology
  • placebo effect
  • preclinical
  • schizophrenia
  • treatment efficacy

ASJC Scopus subject areas

  • Pharmacology, Toxicology and Pharmaceutics(all)
  • Pharmacology (medical)

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