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Table 2 Characteristics of drug trials approved in 2010-2011

From: Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review

  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)
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