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Table 1 Operational characteristics of the clinical program by region

From: Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer’s disease clinical program

  Eastern Europe/Turkey Western Europe/Israel USA/Canada South America/Mexico Asia Australia/South Africa
Sites that screened at least 1 patient 83 135 132 45 27 16
 Randomized 0 patients 1 6 19 1 5 2
 Randomized 1 patient only 2 14 23 2 4 2
 Randomized 0–1 patients (%) 3 (3.6) 20 (14.8) 42 (31.8) 3 (6.7) 9 (33.3) 4 (25.0)
Patients screened per montha 1.23 1.78 1.41 2.03 2.07 1.98
Patients randomized per monthb 0.84 1.22 0.58 1.30 0.92 0.98
Randomization ratec 0.69 0.64 0.48 0.66 0.51 0.54
Completion rated 0.89 0.90 0.89 0.88 0.90 0.86
Protocol deviation ratee 1.79 2.33 1.35 2.64 1.47 1.44
  1. aMean of values for each site (number of patients screened/duration of screening period in months). Screening period was defined as the time from first patient screened to last patient screened at the site; sites that screened patients for a period of < 7 days were assigned a screening period of 7 days for this calculation
  2. bMean of values for each site (number of patients randomized/duration of screening period in months). Screening period was defined as the time from first patient screened to last patient screened at the site; sites that screened patients for a period of < 7 days were assigned a screening period of 7 days for this calculation
  3. cMean of values for each site (number of patients randomized/number of patients screened)
  4. dTotal number of patients completed across all sites/total number of patients randomized across all sites
  5. eMean of values for each site (number of protocol deviations throughout the study/number of patients screened)