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

Table 1 Operational characteristics of the clinical program by region

	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 month^a	1.23	1.78	1.41	2.03	2.07	1.98
Patients randomized per month^b	0.84	1.22	0.58	1.30	0.92	0.98
Randomization rate^c	0.69	0.64	0.48	0.66	0.51	0.54
Completion rate^d	0.89	0.90	0.89	0.88	0.90	0.86
Protocol deviation rate^e	1.79	2.33	1.35	2.64	1.47	1.44

^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
^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
^cMean of values for each site (number of patients randomized/number of patients screened)
^dTotal number of patients completed across all sites/total number of patients randomized across all sites
^eMean of values for each site (number of protocol deviations throughout the study/number of patients screened)

ISSN: 1758-9193