Assessment of cognitive safety in clinical drug development

Jonathan P. Roiser, Pradeep J. Nathan, Adrian P. Mander, Gabriel Adusei, Kenton H. Zavitz, Andrew D. Blackwell

Research output: Contribution to journalReview ArticleResearchpeer-review

5 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)445-453
Number of pages9
JournalDrug Discovery Today
Issue number3
Publication statusPublished - 1 Mar 2016

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