Table 3 Factors that may effect global Alzheimer's disease clinical trials
Host factors that may affect disease progression |
|---|
   General health and standard of care |
   Education |
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 |
   Translation |
   Acculturation |
   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 |