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Table 3 Factors that may effect global Alzheimer's disease clinical trials

From: Globalization of Alzheimer's disease clinical trials

Host factors that may affect disease progression
   General health and standard of care
Population factors that may affect drug pharmacokinetics
   Body size
   Polymorphisms of drug metabolizing enzymes
Population factors that may affect Alzheimer's disease biology
   Genotypes such as apolipoprotein E ε4 allele carrier status
   Head size
Alzheimer's disease diagnosis
   Attitudes toward aging
   Expertise in AD diagnosis
   Behavioral manifestations of AD
   Availability of advanced diagnostics, such as neuroimaging
Clinical trial instrumentation
   Perspectives on behavioral changes, such as apathy
Cultural effects on measures such as the difficulty of obtaining ADL information where domestic help is widely available
Clinical trial conduct
   Experience of investigators
   Patient and caregiver attitudes
   Training of raters
Institutional review boards and human protection
   Availability of standard AD therapies
Clinical trial data analysis
   Sample size considerations
   Extrapolation of data between countries
   Bridging studies
Regulatory factors
   Multi-regional development program requirements
   Country-specific development program requirements
Sample handling
   Sample collection and export
   Laboratory standardization procedures
Supply line factors
   Importation laws
  1. AD, Alzheimer's disease; ADL, activities of daily living.