TY - JOUR
T1 - A call for clinical trial globalization in Alzheimer's disease and related dementia
AU - for the Diversity and Disparity Professional Interest Area Increasing Sustained Diversity in Clinical Trials Working Group
AU - Llibre-Guerra, Jorge J.
AU - Heavener, Anika
AU - Brucki, Sonia Maria Dozzi
AU - Marante, Juan Pablo Díaz
AU - Pintado-Caipa, Maritza
AU - Chen, Yaohua
AU - Behrens, María Isabel
AU - Hardi, Angela
AU - Admirall-Sanchez, Arianna
AU - Akinyemi, Rufus
AU - Alladi, Suvarna
AU - Dorsman, Karen A.
AU - Rodriguez-Salgado, Ana M.
AU - Solorzano, Joel
AU - Babulal, Ganesh M.
N1 - Funding Information:
The working group to increase sustained diversity in clinical trials is an initiative supported by the Alzheimer's Association, Diversity and Disparity Professional Interest Area, the Global Brain Health Institute, and the Center for the Study of Race, Ethnicity & Equity. The content is solely the responsibility of the authors and does not represent the official views of the supporting institutions. Dr. Llibre‐Guerra's research is supported by the National Institutes of Health–National Institute on Aging (NIH‐NIA) (K01AG073526), the Alzheimer's Association (AARFD‐21‐851415, SG‐20‐690363), the Michael J. Fox Foundation (MJFF‐020770), the Foundation for Barnes‐Jewish Hospital, and the McDonnell Academy. Dr. Ganesh Babulal has had investigator‐initiated research funding from the NIH (R01AG056466, R01AG068183, R01AG067428, R01AG074302) and BrightFocus Foundation (A2021142S).
Funding Information:
The working group to increase sustained diversity in clinical trials is an initiative supported by the Alzheimer's Association, Diversity and Disparity Professional Interest Area, the Global Brain Health Institute, and the Center for the Study of Race, Ethnicity & Equity. The content is solely the responsibility of the authors and does not represent the official views of the supporting institutions. Dr. Llibre-Guerra's research is supported by the National Institutes of Health–National Institute on Aging (NIH-NIA) (K01AG073526), the Alzheimer's Association (AARFD-21-851415, SG-20-690363), the Michael J. Fox Foundation (MJFF-020770), the Foundation for Barnes-Jewish Hospital, and the McDonnell Academy. Dr. Ganesh Babulal has had investigator-initiated research funding from the NIH (R01AG056466, R01AG068183, R01AG067428, R01AG074302) and BrightFocus Foundation (A2021142S).
Publisher Copyright:
© 2023 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.
PY - 2023/7
Y1 - 2023/7
N2 - Background: The burden of Alzheimer's disease and related dementia (ADRD) is projected to disproportionally impact low-middle-income countries (LMICs). However, there is a systematic under-representation of LMICs in ADRD clinical trial platforms. Methods: We aimed to determine the global distribution of ADRD clinical trials and identify existing barriers for conducting clinical trials in LMICs. Primary data sources to identify trial distribution in LMICs included ClinicalTrials.gov and the International Trials Registry Platform. An additional systematic review and expert consensus interviews were conducted to identify barriers for conducting clinical trials in LMICs. Findings: Among 1237 disease-modifying therapies tested in ADRD clinical trials, only 11.6% have been or are conducted in emerging economies (upper-middle income [9.6%] and low-middle income [2.0%]). We identified several limitations for trial implementation including a lack of financial resources, low industry presence, regulatory obstacles, and operational barriers. Interpretation: Although LMICs bear the greatest burden of ADRD globally, substantial development of clinical trial platforms to address this inequity and health disparity is lacking.
AB - Background: The burden of Alzheimer's disease and related dementia (ADRD) is projected to disproportionally impact low-middle-income countries (LMICs). However, there is a systematic under-representation of LMICs in ADRD clinical trial platforms. Methods: We aimed to determine the global distribution of ADRD clinical trials and identify existing barriers for conducting clinical trials in LMICs. Primary data sources to identify trial distribution in LMICs included ClinicalTrials.gov and the International Trials Registry Platform. An additional systematic review and expert consensus interviews were conducted to identify barriers for conducting clinical trials in LMICs. Findings: Among 1237 disease-modifying therapies tested in ADRD clinical trials, only 11.6% have been or are conducted in emerging economies (upper-middle income [9.6%] and low-middle income [2.0%]). We identified several limitations for trial implementation including a lack of financial resources, low industry presence, regulatory obstacles, and operational barriers. Interpretation: Although LMICs bear the greatest burden of ADRD globally, substantial development of clinical trial platforms to address this inequity and health disparity is lacking.
UR - http://www.scopus.com/inward/record.url?scp=85149799787&partnerID=8YFLogxK
U2 - 10.1002/alz.12995
DO - 10.1002/alz.12995
M3 - Article
C2 - 36840622
AN - SCOPUS:85149799787
SN - 1552-5260
VL - 19
SP - 3210
EP - 3221
JO - Alzheimer's and Dementia
JF - Alzheimer's and Dementia
IS - 7
ER -