Table 2 Characteristics of drug trials approved in 2010-2011
Protocols | |
|---|---|
Total, n (%) | 226 (100) |
REC | |
Nijmegen | 74 (32.7) |
Amsterdam | 76 (33.6) |
Leiden | 76 (33.6) |
Year of approval | |
2010 | 123 (54.4) |
2011 | 103 (45.6) |
Sponsor type | |
Non-industry | 91 (40.3) |
Non-industry, supported by industry | 31 (13.7) |
Industry-sponsored | 104 (46.0) |
Number of centres | |
Single centre | 100 (44.2) |
Multicentre | 126 (55.8) |
NL only or international trial | |
NL trial | 131 (58.0) |
International trial | 95 (42.0) |
Phase | |
Phase 1 | 21 (9.3) |
Phase 2 | 62 (27.4) |
Phase 3 | 62 (27.4) |
Phase 4 | 17 (7.5) |
Other | 64 (28.3) |
Study drug registered in NL | |
Yes, for the same indication/dosage as studied in protocol | 50 (22.1) |
Yes, for different indication/dosage than studied in protocol | 74 (32.7) |
No | 79 (35.0) |
Not reported whether drug was registered in NL | 23 (10.2) |
Type of subjects | |
Adult subjects capable of giving informed consent | 208 (92.0) |
Adult subjects not capable of giving informed consent and/or minors <18 years | 7 (3.1) |
Adult subjects capable of giving informed consent and adults not capable of giving informed consent or minors <18 years | 11 (4.9) |
Anticipated number of subjects, median (IQR) | |
Number of subjects (total) | 59 (24–240) |
Number of subjects (NL trials) | 34 (20–60) |
Number of subjects (international trials) | 300 (120–800) |