Number of patients in pivotal trials submitted in MAAs to the EMA 2005–2009
| Region | Number of patients | % | Number of sites | % | Number of patients per site |
|---|---|---|---|---|---|
| EU/EEA/EFTA | 231,369 | 38.8 | 16,063 | 36.5 | 14 |
| North America | 209,750 | 35.2 | 19,362 | 44.0 | 11 |
| Central/South America | 54,657 | 9.2 | 2,625 | 6.0 | 21 |
| Middle East/Asia/Pacific | 46,505 | 7.9 | 2,577 | 5.9 | 18 |
| CIS region | 22,664 | 3.8 | 1,566 | 3.6 | 14 |
| Africa | 17,915 | 3 | 707 | 1.6 | 25 |
| Australia–New Zealand | 8,678 | 1.5 | 919 | 2.1 | 9 |
| Eastern Europe–non EU | 4,042 | 0.7 | 215 | 0.5 | 19 |
| Total | 595,580 | 44,034 |
2005–2009
| No of CTs | No of sites | No of patients | No of patients per trial | |
|---|---|---|---|---|
| China | 17 | 185 | 4,417 | 260 |
| India | 65 | 528 | 8,920 | 137 |
| Korea | 58 | 291 | 3,320 | 57 |
Source: European Medicines Agency (EMA) clinical trials submitted in marketing authorization applications to the EMA overview of patient recruitment and the geographical location of investigator sites, 5 November 2010, EMA/INS/GCP/154352/2010 Compliance and Inspection
Subjects and sites by country for marketing applications approved in the fiscal year 2008
| Country | Number of patients | % of total patients | Number of sites | % of total sites | Number of patients per site |
|---|---|---|---|---|---|
| China | 424 | 0.5 | 32 | 0.3 | 13 |
| India | 384 | 0.4 | 49 | 0.4 | 8 |
| Korea | 409 | 0.4 | 32 | 0.3 | 13 |
| USA | 40,039 | 43.1 | 5,098 | 45.4 | 8 |
| All countries | 92,859 | 11,227 |
Source: Challenges to FDA’s ability to monitor and inspect foreign clinical trials, DHSS, June 2010