Table 2.
Types, purposes, endpoints and enrollment of Egyptian studies in 3 trial registries.
CTGR | ICTRP | PACTR | |
---|---|---|---|
n (%) | n (%) | n (%) | |
548 | 686 | 56 | |
Study types | |||
Interventional | 458 (83.6) | 580 (84.5) | 56 (100.0) |
Observational | 87 (15.9) | 104 (15.2) | 0 (0) |
Expanded access | 3 (0.5) | 2 (0.3) | 0 (0) |
Purpose | |||
Treatment | 379 (69.2) | –a | 41 (73.2) |
Prevention | 46 (8.4) | –a | 7 (12.5) |
Supportive care | 9 (1.6) | –a | 5 (8.9) |
Diagnostic | 6 (1.1) | –a | 2 (3.6) |
Health services research | 5 (0.9) | –a | 0 (0) |
Screening | 2 (0.4) | –a | 0 (0) |
Education counseling training | 0 (0) | –a | 1 (1.8) |
Others/not mentioned | 101 (18.4) | –a | 0 (0) |
End point classification | |||
Safety/Efficacy study | 269 (49.1) | –a | –a |
Efficacy study | 107 (19.5) | –a | –a |
Safety Study | 5 (0.9) | –a | –a |
Pharmacokinetics study | 3 (0.5) | –a | –a |
Bio-equivalence study | 1 (0.2) | –a | –a |
Pharmacokinetics | 1 (0.2) | –a | –a |
Pharmacokinetics/dynamics | 1 (0.2) | –a | –a |
Others/not mentioned | 161 (29.4) | –a | –a |
Gender | |||
Both | 391 (71.4) | 442 (64.4) | 37 (66.1) |
Female | 137 (25.0) | 176 (25.7) | 18 (32.1) |
Male | 20 (3.6) | 25 (3.6) | 1 (1.8) |
Not mentioned | 0 (0) | 43 (6.3) | 0 (0) |
Age | |||
Child (<18 year) | 37 (6.8) | 68 (9.9) | 4 (7.1) |
Adult (18–65 year) | 174 (31.8) | 299 (43.6) | 35 (62.5) |
Senior (>65 year in WHO) | 1 (0.2) | 1 (0.1) | 0 (0) |
Child and adult | 35 (6.4) | 22 (3.2) | 2 (3.6) |
Adult and senior | 233 (42.5) | 142 (20.7) | 12 (21.4) |
Child, adult and senior | 68 (12.4) | 18 (2.6) | 3 (5.4) |
Number of enrolled subjects | |||
Median (IQR) | 155 (70–538) | 150 (60–532) | 63 (41–100) |
CTGR: U.S. ClinicalTrials.gov registry, ICTRP: WHO International Clinical Trials Registry Platform, PACTR: Pan-African Clinical Trials Registry, IQR: inter-quartile range.
Not included.