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Committee on High‐quality Alzheimer's Disease Studies (CHADS) consensus report
Author(s) -
Jicha Greg A.,
Abner Erin L.,
Arnold Steven E.,
Carrillo Maria C.,
Dodge Hiroko H.,
Edland Steven D.,
Fargo Keith N.,
Feldman Howard H.,
Goldstein Larry B.,
Hendrix James,
Peters Ruth,
Robillard Julie M.,
Schneider Lon S.,
Titiner Jodi R.,
Weber Christopher J.
Publication year - 2022
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1002/alz.12461
Subject(s) - clinical trial , protocol (science) , population , medicine , alternative medicine , family medicine , political science , pathology , environmental health
Background Consensus guidance for the development and identification of high‐quality Alzheimer's disease clinical trials is needed for protocol development and conduct of clinical trials. Methods An ad hoc consensus committee was convened in conjunction with the Alzheimer's Association to develop consensus recommendations. Results Consensus was readily reached for the need to provide scientific justification, registration of trials, institutional review board oversight, conflict of interest disclosure, funding source disclosure, defined trial population, recruitment resources, definition of the intervention, specification of trial duration, appropriate payment for participant engagement, risk‐benefit disclosure as part of the consent process, and the requirement to disseminate and/or publish trial results even if the study is negative. Conclusions This consensus guidance should prove useful for the protocol development and conduct of clinical trials, and may further provide a platform for the development of education materials that may help guide appropriate clinical trial participation decisions for potential trial participants and the general public.