Race reporting and disparities in clinical trials on Alzheimer's disease: A systematic review

Marco Canevelli; Giuseppe Bruno; Giulia Grande; Federica Quarata; Riccardo Raganato; Francesca Remiddi; Martina Valletta; Valerio Zaccaria; Nicola Vanacore; Matteo Cesari

doi:10.1016/j.neubiorev.2019.03.020

Race reporting and disparities in clinical trials on Alzheimer's disease: A systematic review

Neurosci Biobehav Rev. 2019 Jun:101:122-128. doi: 10.1016/j.neubiorev.2019.03.020. Epub 2019 Apr 1.

Affiliations

¹ Department of Human Neuroscience, "Sapienza" University, Rome, Italy; National Center for Disease Prevention and Health Promotion, National Institute of Health, Rome, Italy. Electronic address: marco.canevelli@gmail.com.
² Department of Human Neuroscience, "Sapienza" University, Rome, Italy.
³ Aging Research Center, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet and Stockholm University, Stockholm, Sweden.
⁴ National Center for Disease Prevention and Health Promotion, National Institute of Health, Rome, Italy.
⁵ Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy; Geriatric Unit, Department of Clinical Sciences and Community Health, University of Milan, Milano, Italy.

PMID: 30946856
DOI: 10.1016/j.neubiorev.2019.03.020

Abstract

Introduction: Race is an important health determinant and should adequately be considered in research and drug development protocols targeting Alzheimer's disease (AD).

Methods: A systematic review of available randomized controlled trials (RCTs) on the currently marketed treatments for AD was conducted with the aim of 1) documenting the reporting of race, and 2) exploring the impact of race on the efficacy and safety/tolerability of the considered medications.

Results: Overall, 59.2% of the 49 retained RCTs reported information concerning the race of participants. Only a striking minority of enrolled patients was constituted of blacks and Hispanics. None on the retained studies reported results on the efficacy and safety/tolerability of the tested treatment separately for racial groups nor performed sensitivity analyses accounting for the race of participants.

Discussion: Race has insufficiently been reported in previous interventional studies on AD. Its potential association with the effectiveness and safety/tolerability of the tested medications has completely been neglected.

Keywords: Alzheimer’s disease; Dementia; External validity; Precision medicine; Race; Randomized controlled trial.

Publication types

Systematic Review

MeSH terms

Alzheimer Disease / therapy*
Data Collection
Ethnicity / statistics & numerical data*
Healthcare Disparities / statistics & numerical data*
Humans
Minority Groups / statistics & numerical data*
Randomized Controlled Trials as Topic