Evidence map›Paper›PMID 26610416›Full record

ReviewDrug discovery today2016

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

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Drug discovery today, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Jonathan P RoiserInstitute of Cognitive Neuroscience, University College London, London, UK. Electronic address: j.roiser@ucl.ac.uk.
Pradeep J NathanDepartment of Psychiatry, University of Cambridge, Cambridge, UK; Neuroscience Center of Excellence, inVentiv Health, Maidenhead, UK; School of Psychological Sciences, Monash University, Clayton, Australia.
Adrian P ManderMRC Biostatistics Unit, University of Cambridge, Cambridge, UK.
Gabriel AduseiCambridge Cognition Limited, Bottisham, Cambridge, UK.
Kenton H ZavitzCambridge Cognition Limited, Bottisham, Cambridge, UK.
Andrew D BlackwellDepartment of Psychiatry, University of Cambridge, Cambridge, UK; Cambridge Cognition Limited, Bottisham, Cambridge, UK.

Funding

Medical Research Council G0800860Medical Research Council MC_UP_1302/2Medical Research Council MC_UU_00002/3
6 · The paper itself

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.

Indexed as

CognitionCognition DisordersDrug-Related Side Effects and Adverse ReactionsHumansRandomized Controlled Trials as TopicResearch Design

Identifiers

PMID26610416
PMCPMC4863933

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.