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

doi:10.1586/17512433.2016.1135734

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 journal › Review article › peer-review

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 language	English (US)
Pages (from-to)	591-604
Number of pages	14
Journal	Expert Review of Clinical Pharmacology
Volume	9
Issue number	4
DOIs	https://doi.org/10.1586/17512433.2016.1135734
State	Published - Apr 2 2016
Externally published	Yes

Keywords

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

ASJC Scopus subject areas

General Pharmacology, Toxicology and Pharmaceutics
Pharmacology (medical)

Access to Document

10.1586/17512433.2016.1135734

Cite this

@article{db2f8b1aa8964ba286e30b9bf8d93b3b,

title = "Methodological issues associated with preclinical drug development and increased placebo effects in schizophrenia clinical trials",

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",

author = "Brown, {Matt A.} and Bishnoi, {Ram J.} and Sara Dholakia and Velligan, {Dawn I.}",

note = "Publisher Copyright: {\textcopyright} 2016 Taylor & Francis.",

year = "2016",

month = apr,

day = "2",

doi = "10.1586/17512433.2016.1135734",

language = "English (US)",

volume = "9",

pages = "591--604",

journal = "Expert Review of Clinical Pharmacology",

issn = "1751-2433",

publisher = "Expert Reviews Ltd.",

number = "4",

}

TY - JOUR

T1 - Methodological issues associated with preclinical drug development and increased placebo effects in schizophrenia clinical trials

AU - Brown, Matt A.

AU - Bishnoi, Ram J.

AU - Dholakia, Sara

AU - Velligan, Dawn I.

PY - 2016/4/2

Y1 - 2016/4/2

N2 - 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.

AB - 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.

KW - clinical trials

KW - drug development

KW - methodological issues

KW - pharmacology

KW - placebo effect

KW - preclinical

KW - schizophrenia

KW - treatment efficacy

UR - http://www.scopus.com/inward/record.url?scp=84955071032&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84955071032&partnerID=8YFLogxK

U2 - 10.1586/17512433.2016.1135734

DO - 10.1586/17512433.2016.1135734

M3 - Review article

AN - SCOPUS:84955071032

SN - 1751-2433

VL - 9

SP - 591

EP - 604

JO - Expert Review of Clinical Pharmacology

JF - Expert Review of Clinical Pharmacology

IS - 4

ER -

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

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this