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Table 3 Characteristics of included trials

From: Impact of investigator initiated trials and industry sponsored trials on medical practice (IMPACT): rationale and study design

Characteristics IIT
Public Germany gov
No. of trials (%)
IIT
Public Germany
other
No. of trials (%)
IIT
Public Germany
No. of trials (%)
IIT
Public International
No. of trials (%)
*IST
Commercial Germany
No. of trials (%)
IST
Commercial International
No. of trials (%)
Total
No. of trials
(%)
Total 60 60 120 (100) 200 (100) 171 (100) 200 (100) 691 (100)
Registered ina
ClinicalTrials.gov 32 (53) 16 (27) 48 (40) 200 (100) 158 (92) 200 (100) 606 (88)
 DRKSb 14 (23) 48 (80) 62 (52) 19 (11) 81 (12)
 ISRCTNc 27 (45) 5 (8) 32 (27) 3 (1) 35 (5)
 EudraCTd 40 (67) 10 (17) 50 (42) 18 (9) 88 (52) 33 (17) 189 (27)
Study status
 Completed 43 (72) 59 (98) 102 (85) 200 (100) 170 (100) 200 (100) 672 (97)
 Prematurely ended 12 (20) 1 (2) 13 (11)   1 (< 1)   14 (2)
 Still ongoinge 5 (8) 5 (4)     5 (< 1)
Collaboration
 International 19 (32) 7 (12) 26 (22) 44 (22) 71 (42) 69 (35) 210 (30)
 National 40 (66) 53 (88) 93 (78) 156 (78) 100 (58) 131 (65) 479 (69)
 Unclear 1 (2) 1 (< 1) 2 (< 1)
Study size (Median = 150)
  > 150 46 (76) 28 (47) 74 (62) 81 (40) 74 (43) 115 (58) 344 (50)
  ≤ 150 13 (22) 32 (53) 45 (38) 119 (60) 97 (57) 85 (42) 346 (50)
 Unclear 1 (2) 1 (< 1) 1 (< 1)
Number of primary outcome(s)
 0 1 (1) 1 (< 1)
 1 44 (73) 44 (73) 88 (73) 152 (76) 122 (71) 133 (67) 495 (72)
  > 1 (range 2–36) 16 (27) 16 (27) 32 (27) 48 (24) 48 (28) 67 (33) 195 (28)
Study phase drug trialsf
 Total 41 (68) 15 (25) 56 (47) 93 (47) 93 (54) 93 (47) 335 (48)
 2 9 (15) 5 (8) 14 (12) 23 (12) 23 (13) 23 (12) 83 (12)
 3 20 (33) 7 (12) 27 (22) 45 (23) 45 (26) 45 (23) 162 (23)
 4 12 (20) 3 (5) 15 (13) 25 (13) 25 (15) 25 (13) 90 (13)
Study phase non-drug trialsg
Total 19 (32) 45 (75) 64 (53) 107 (53) 78 (46) 107 (53) 356 (52)
 A 9 (15) 9 (7) 15 (7) 11 (7) 15 (7) 50 (7)
 B 16 (27) 33 (55) 49 (41) 82 (41) 43 (25) 82 (41) 256 (37)
 C 3 (5) 3 (5) 6 (5) 10 (5) 24 (14) 10 (5) 50 (7)
  1. a Several trials were registered in more than one trials registry, i.e. numbers do not sum up to the total numbers (100%)
  2. b DRKS: German Clinical Trials Register
  3. c ISRCTN: International Standard Randomized Controlled Trials Number registry
  4. d EudraCT: European Union Drug Regulating Authorities Clinical Trials Database
  5. e Status as of 24 April 2020
  6. f 15 drug trials of phase 2–3 were counted as phase 2; 24 non-drug trials of phase A-B were counted as phase A
  7. g In the sub-cohort “Commercial Germany”, we included all non-drug trials available in the study registries, resulting in slightly differing distributions of study phases among the 4 sub-cohorts