TY - JOUR
T1 - Assessment of cognitive safety in clinical drug development
AU - Roiser, Jonathan P.
AU - Nathan, Pradeep J.
AU - Mander, Adrian P.
AU - Adusei, Gabriel
AU - Zavitz, Kenton H.
AU - Blackwell, Andrew D.
PY - 2016/3/1
Y1 - 2016/3/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84950239610&partnerID=8YFLogxK
U2 - 10.1016/j.drudis.2015.11.003
DO - 10.1016/j.drudis.2015.11.003
M3 - Review Article
C2 - 26610416
AN - SCOPUS:84950239610
SN - 1359-6446
VL - 21
SP - 445
EP - 453
JO - Drug Discovery Today
JF - Drug Discovery Today
IS - 3
ER -