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General health and standard of care
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Education
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Population factors that may affect drug pharmacokinetics
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Body size
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Polymorphisms of drug metabolizing enzymes
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|
Population factors that may affect Alzheimer's disease biology
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Genotypes such as apolipoprotein E ε4 allele carrier status
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Head size
|
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Alzheimer's disease diagnosis
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Attitudes toward aging
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|
Expertise in AD diagnosis
|
|
Behavioral manifestations of AD
|
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Availability of advanced diagnostics, such as neuroimaging
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|
Clinical trial instrumentation
|
|
Translation
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|
Acculturation
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Perspectives on behavioral changes, such as apathy
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Cultural effects on measures such as the difficulty of obtaining ADL information where domestic help is widely available
|
|
Clinical trial conduct
|
|
Experience of investigators
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|
Patient and caregiver attitudes
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|
Training of raters
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|
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
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