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Brown MA, Bishnoi RJ, Dholakia S, et al. Methodological issues associated with preclinical drug development and increased placebo effects in schizophrenia clinical trials. Expert Rev Clin Pharmacol. 2016;9(4):591-604doi: 10.1586/17512433.2016.1135734.
Brown, M. A., Bishnoi, R. J., Dholakia, S., & Velligan, D. I. (2016). Methodological issues associated with preclinical drug development and increased placebo effects in schizophrenia clinical trials. Expert review of clinical pharmacology, 9(4), 591-604. https://doi.org/10.1586/17512433.2016.1135734
Brown, Matt A, et al. "Methodological issues associated with preclinical drug development and increased placebo effects in schizophrenia clinical trials." Expert review of clinical pharmacology vol. 9,4 (2016): 591-604. doi: https://doi.org/10.1586/17512433.2016.1135734
Brown MA, Bishnoi RJ, Dholakia S, Velligan DI. Methodological issues associated with preclinical drug development and increased placebo effects in schizophrenia clinical trials. Expert Rev Clin Pharmacol. 2016 Apr;9(4):591-604. doi: 10.1586/17512433.2016.1135734. Epub 2016 Jan 20. PMID: 26696325.
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Expert Rev Clin Pharmacol. 2016 Apr;9(4):591-604. doi: 10.1586/17512433.2016.1135734. Epub 2016 Jan 20.

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

Expert review of clinical pharmacology

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

Affiliations

  1. a Department of Psychiatry , University of Texas Health Science Center at San Antonio , San Antonio , TX , USA.

PMID: 26696325 DOI: 10.1586/17512433.2016.1135734

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.

Keywords: clinical trials; drug development; methodological issues; pharmacology; placebo effect; preclinical; schizophrenia; treatment efficacy

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