Decentralized clinical trials for medications to reduce the risk of dementia: consensus report and guidance

Leanne Howard; Carla Abdelnour; Erin L. Abner; Ricardo F. Allegri; Hiroko H. Dodge; Serge Gauthier; Camilla M. Hoyos; Gregory A. Jicha; Patrick G. Kehoe; Catherine J. Mummery; Adesola Ogunniyi; Nikolaos Scarmeas; Xiaoying Chen; Jodie R. Titiner; Christopher R. Weber; Clinical Trial Methodology Working review group members; Ruth Peters

doi:10.1002/alz.13891

Decentralized clinical trials for medications to reduce the risk of dementia: consensus report and guidance

Leanne Howard, Carla Abdelnour, Erin L. Abner, Ricardo F. Allegri, Hiroko H. Dodge, Serge Gauthier, Camilla M. Hoyos, Gregory A. Jicha, Patrick G. Kehoe, Catherine J. Mummery, Adesola Ogunniyi, Nikolaos Scarmeas, Xiaoying Chen, Jodie R. Titiner, Christopher R. Weber, Clinical Trial Methodology Working review group members, Ruth Peters^*

^*Corresponding author for this work

Department of Health Sciences

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

36 Downloads (Pure)

Abstract

INTRODUCTION: Recent growth in the functionality and use of technology has prompted an increased interest in the potential for remote or decentralized clinical trials in dementia. There are many potential benefits associated with decentralized medication trials, but we currently lack specific recommendations for their delivery in the dementia field. METHODS: A modified Delphi method engaged an expert panel to develop recommendations for the conduct of decentralized medication trials in dementia prevention. A working group of researchers and clinicians with expertise in dementia trials further refined the recommendations. RESULTS: Overall, the recommendations support the delivery of decentralized trials in dementia prevention provided adequate safety checks and balances are included. A total of 40 recommendations are presented, spanning aspects of decentralized clinical trials, including safety, dispensing, outcome assessment, and data collection. DISCUSSION: These recommendations provide an accessible, pragmatic guide for the design and conduct of remote medication trials for dementia prevention. Highlights: Clinical trials of medication have begun adopting decentralized approaches. Researchers in the field lack guidance on what would be appropriate circumstances and frameworks for what would be appropriate circumstances and frameworks for the use of decentralized trial methods in dementia prevention. The present report provides consensus-based expert recommendations for decentralized clinical trials for dementia prevention.

Original language	English
Pages (from-to)	4625-4634
Number of pages	10
Journal	Alzheimer's and Dementia
Volume	20
Issue number	7
DOIs	https://doi.org/10.1002/alz.13891
Publication status	Published - Jul 2024

Bibliographical note

Copyright the Author(s) 2024. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

decentralized clinical trials
Delphi process
dementia prevention
recommendations
remote clinical trials

Access to Document

10.1002/alz.13891Licence: CC BY

Publisher version (open access)Final published version, 1.11 MBLicence: CC BY

Cite this

Howard, L., Abdelnour, C., Abner, E. L., Allegri, R. F., Dodge, H. H., Gauthier, S., Hoyos, C. M., Jicha, G. A., Kehoe, P. G., Mummery, C. J., Ogunniyi, A., Scarmeas, N., Chen, X., Titiner, J. R., Weber, C. R., Clinical Trial Methodology Working review group members, & Peters, R. (2024). Decentralized clinical trials for medications to reduce the risk of dementia: consensus report and guidance. Alzheimer's and Dementia, 20(7), 4625-4634. https://doi.org/10.1002/alz.13891

@article{0cbc6669d238409e800efd615aa9c5f8,

title = "Decentralized clinical trials for medications to reduce the risk of dementia: consensus report and guidance",

abstract = "INTRODUCTION: Recent growth in the functionality and use of technology has prompted an increased interest in the potential for remote or decentralized clinical trials in dementia. There are many potential benefits associated with decentralized medication trials, but we currently lack specific recommendations for their delivery in the dementia field. METHODS: A modified Delphi method engaged an expert panel to develop recommendations for the conduct of decentralized medication trials in dementia prevention. A working group of researchers and clinicians with expertise in dementia trials further refined the recommendations. RESULTS: Overall, the recommendations support the delivery of decentralized trials in dementia prevention provided adequate safety checks and balances are included. A total of 40 recommendations are presented, spanning aspects of decentralized clinical trials, including safety, dispensing, outcome assessment, and data collection. DISCUSSION: These recommendations provide an accessible, pragmatic guide for the design and conduct of remote medication trials for dementia prevention. Highlights: Clinical trials of medication have begun adopting decentralized approaches. Researchers in the field lack guidance on what would be appropriate circumstances and frameworks for what would be appropriate circumstances and frameworks for the use of decentralized trial methods in dementia prevention. The present report provides consensus-based expert recommendations for decentralized clinical trials for dementia prevention.",

keywords = "decentralized clinical trials, Delphi process, dementia prevention, recommendations, remote clinical trials",

author = "Leanne Howard and Carla Abdelnour and Abner, {Erin L.} and Allegri, {Ricardo F.} and Dodge, {Hiroko H.} and Serge Gauthier and Hoyos, {Camilla M.} and Jicha, {Gregory A.} and Kehoe, {Patrick G.} and Mummery, {Catherine J.} and Adesola Ogunniyi and Nikolaos Scarmeas and Xiaoying Chen and Titiner, {Jodie R.} and Weber, {Christopher R.} and {Clinical Trial Methodology Working review group members} and Ruth Peters",

note = "Copyright the Author(s) 2024. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.",

year = "2024",

month = jul,

doi = "10.1002/alz.13891",

language = "English",

volume = "20",

pages = "4625--4634",

journal = "Alzheimer's and Dementia",

issn = "1552-5260",

publisher = "Wiley-Blackwell, Wiley",

number = "7",

}

Howard, L, Abdelnour, C, Abner, EL, Allegri, RF, Dodge, HH, Gauthier, S, Hoyos, CM, Jicha, GA, Kehoe, PG, Mummery, CJ, Ogunniyi, A, Scarmeas, N, Chen, X, Titiner, JR, Weber, CR, Clinical Trial Methodology Working review group members & Peters, R 2024, 'Decentralized clinical trials for medications to reduce the risk of dementia: consensus report and guidance', Alzheimer's and Dementia, vol. 20, no. 7, pp. 4625-4634. https://doi.org/10.1002/alz.13891

TY - JOUR

T1 - Decentralized clinical trials for medications to reduce the risk of dementia

T2 - consensus report and guidance

AU - Howard, Leanne

AU - Abdelnour, Carla

AU - Abner, Erin L.

AU - Allegri, Ricardo F.

AU - Dodge, Hiroko H.

AU - Gauthier, Serge

AU - Hoyos, Camilla M.

AU - Jicha, Gregory A.

AU - Kehoe, Patrick G.

AU - Mummery, Catherine J.

AU - Ogunniyi, Adesola

AU - Scarmeas, Nikolaos

AU - Chen, Xiaoying

AU - Titiner, Jodie R.

AU - Weber, Christopher R.

AU - Clinical Trial Methodology Working review group members

AU - Peters, Ruth

N1 - Copyright the Author(s) 2024. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

PY - 2024/7

Y1 - 2024/7

N2 - INTRODUCTION: Recent growth in the functionality and use of technology has prompted an increased interest in the potential for remote or decentralized clinical trials in dementia. There are many potential benefits associated with decentralized medication trials, but we currently lack specific recommendations for their delivery in the dementia field. METHODS: A modified Delphi method engaged an expert panel to develop recommendations for the conduct of decentralized medication trials in dementia prevention. A working group of researchers and clinicians with expertise in dementia trials further refined the recommendations. RESULTS: Overall, the recommendations support the delivery of decentralized trials in dementia prevention provided adequate safety checks and balances are included. A total of 40 recommendations are presented, spanning aspects of decentralized clinical trials, including safety, dispensing, outcome assessment, and data collection. DISCUSSION: These recommendations provide an accessible, pragmatic guide for the design and conduct of remote medication trials for dementia prevention. Highlights: Clinical trials of medication have begun adopting decentralized approaches. Researchers in the field lack guidance on what would be appropriate circumstances and frameworks for what would be appropriate circumstances and frameworks for the use of decentralized trial methods in dementia prevention. The present report provides consensus-based expert recommendations for decentralized clinical trials for dementia prevention.

AB - INTRODUCTION: Recent growth in the functionality and use of technology has prompted an increased interest in the potential for remote or decentralized clinical trials in dementia. There are many potential benefits associated with decentralized medication trials, but we currently lack specific recommendations for their delivery in the dementia field. METHODS: A modified Delphi method engaged an expert panel to develop recommendations for the conduct of decentralized medication trials in dementia prevention. A working group of researchers and clinicians with expertise in dementia trials further refined the recommendations. RESULTS: Overall, the recommendations support the delivery of decentralized trials in dementia prevention provided adequate safety checks and balances are included. A total of 40 recommendations are presented, spanning aspects of decentralized clinical trials, including safety, dispensing, outcome assessment, and data collection. DISCUSSION: These recommendations provide an accessible, pragmatic guide for the design and conduct of remote medication trials for dementia prevention. Highlights: Clinical trials of medication have begun adopting decentralized approaches. Researchers in the field lack guidance on what would be appropriate circumstances and frameworks for what would be appropriate circumstances and frameworks for the use of decentralized trial methods in dementia prevention. The present report provides consensus-based expert recommendations for decentralized clinical trials for dementia prevention.

KW - decentralized clinical trials

KW - Delphi process

KW - dementia prevention

KW - recommendations

KW - remote clinical trials

UR - http://www.scopus.com/inward/record.url?scp=85194915121&partnerID=8YFLogxK

U2 - 10.1002/alz.13891

DO - 10.1002/alz.13891

M3 - Article

C2 - 38824659

AN - SCOPUS:85194915121

SN - 1552-5260

VL - 20

SP - 4625

EP - 4634

JO - Alzheimer's and Dementia

JF - Alzheimer's and Dementia

IS - 7

ER -

Decentralized clinical trials for medications to reduce the risk of dementia: consensus report and guidance

Abstract

Bibliographical note

Keywords

Access to Document

Other files and links

Fingerprint

Cite this