A call for clinical trial globalization in Alzheimer's disease and related dementia
Alzheimers Dement. 2023 Jul;19(7):3210-3221. doi: 10.1002/alz.12995. Epub 2023 Feb 25.
ABSTRACT
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.
PMID:36840622 | DOI:10.1002/alz.12995
Authors
Jorge Llibre Guerra, MD, MS
Behavioral Neurologist
Maritza Pintado-Caipa, MD
Neurologist
Yaohua Chen, MD, PhD
Neurogeriatrician
Arianna Almirall Sanchez, MD, MSc
General Practitioner, Bio-statistician
Rufus Akinyemi, MBBS, MSc, PhD, MWACP, FMCP
Neurologist
Ana Margarita Rodriguez Salgado, MSc
Neuropsychologist