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Assessment of cognitive safety in clinical drug development

Roiser, JP; Nathan, PJ; Mander, AP; Adusei, G; Zavitz, KH; Blackwell, AD; (2015) Assessment of cognitive safety in clinical drug development. Drug Discovery Today , 21 (3) pp. 445-453. 10.1016/j.drudis.2015.11.003. Green open access

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Abstract

Cognitive impairment is increasingly recognised as an important potential adverse effect of medication. However, many drug development programmes do not incorporate sensitive cognitive measurements. Here, we review the rationale for cognitive safety assessment, and explain several basic methodological principles for measuring cognition during clinical drug development, including study design and statistical analysis, from Phase I through to postmarketing. The crucial issue of how cognition should be assessed is emphasized, especially the sensitivity of measurement. We also consider how best to interpret the magnitude of any identified effects, including comparison with benchmarks. We conclude by discussing strategies for the effective communication of cognitive risks.

Type: Article
Title: Assessment of cognitive safety in clinical drug development
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.drudis.2015.11.003
Publisher version: http://doi.org/10.1016/j.drudis.2015.11.003
Language: English
Additional information: This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/
Keywords: Science & Technology, Life Sciences & Biomedicine, Pharmacology & Pharmacy, BLOOD-BRAIN-BARRIER, PARKINSONS-DISEASE, IMPAIRMENT, DEMENTIA, ANTICHOLINERGICS, ANTIHISTAMINES, SCHIZOPHRENIA, PERFORMANCE, DEPRESSION, MANAGEMENT
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Div of Psychology and Lang Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Div of Psychology and Lang Sciences > Institute of Cognitive Neuroscience
URI: https://discovery.ucl.ac.uk/id/eprint/1480983
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