Table 1. Study characteristics.
Study characteristics | REC Freiburg | Other RECs1 | ||||
---|---|---|---|---|---|---|
Controlled trial | Single arm trial | Cohort study | Total NPSs | RCTs | RCTs | |
Total n | 27 (100) | 158 (100) | 56 (100) | 241 (100) | 306 (100) | 711 (100) |
Sample size provided | 27 (100) | 154 (97) | 54 (96) | 235 (98) | 302 (99) | 697 (98) |
Median; IQR | 30; 20–48 | 60; 30–238 | 115;50–300 | 60; 30–230 | 200; 81–449 | 240; 60–600 |
Centre status | ||||||
Single centre | 25 (93) | 46 (29) | 37 (66) | 108 (45) | 70 (23) | 191 (27) |
Multi centre—national | 1 (4) | 45 (29) | 13 (23) | 59 (25) | 67 (22) | 92 (13) |
Multi centre—international | 1 (4) | 66 (42) | 6 (11) | 73 (30) | 155 (51) | 404 (57) |
Unclear/missing | 0 | 1 (1) | 0 | 1 (<1) | 14 (5) | 24 (3) |
Labelled as pilot study | 14 (52) | 34 (22) | 19 (34) | 67 (28) | 36 (12) | 47 (7) |
Sponsorship | ||||||
Industry2 | 9 (33) | 99 (63) | 10 (18) | 118 (49) | 182 (59) | 455 (64) |
Non-industry | 18 (67) | 59 (37) | 46 (82) | 123 (51) | 124 (41) | 256 (36) |
Medical field | ||||||
Oncology | 3 (11) | 40 (25) | 7 (12) | 50 (21) | 66 (22) | 90 (13) |
Cardiovascular | 0 (0) | 5 (3) | 3 (5) | 8 (3) | 27 (9) | 90 (13) |
Infectious disease | 2 (7) | 12 (8) | 5 (9) | 19 (8) | 23 (8) | 78 (11) |
Endocrinology | 1 (4) | 3 (2) | 1 (2) | 5 (2) | 14 (5) | 64 (9) |
Neurology | 3 (11) | 18 (11) | 8 (14) | 29 (12) | 27 (9) | 39 (5) |
Gastroenterology | 0 | 1 (1) | 1 (2) | 2 (1) | 12 (4) | 52 (7) |
Respiratory | 0 | 4 (3) | 3 (5) | 7 (2) | 15 (5) | 46 (6) |
Psychiatry | 3 (11) | 15 (9) | 4 (7) | 22 (9) | 20 (7) | 25 (4) |
Dermatology | 4 (15) | 8 (5) | 2 (4) | 14 (6) | 21 (7) | 16 (2) |
Haematology | 0 | 9 (6) | 2 (4) | 11 (5) | 9 (3) | 27 (4) |
Dental / facial surgery | 7 (16) | 6 (4) | 1 (2) | 14 (6) | 5 (2) | 1 (0) |
Other | 4 (15) | 37 (23) | 19 (34) | 60 (25) | 67 (22) | 183 (26) |
Age group | ||||||
Adult | 26 (96) | 148 (94) | 47 (84) | 221 (92) | 283 (92) | 648 (91) |
Paediatric | 1 (4) | 10 (6) | 9 (16) | 20 (8) | 23 (8) | 63 (9) |
Participants | ||||||
Patients | 18 (67) | 142 (90) | 45 (80) | 205 (85) | 282 (92) | 612 (86) |
Healthy volunteers | 8 (30) | 11 (7) | 3 (5) | 22 (9) | 24 (8) | 99 (14) |
Both | 1 (4) | 5 (3) | 8 (14) | 14 (6) | 0 | 0 |
Published in peer-reviewed journal | 15 (56) | 74 (47) | 29 (52) | 118 (49) | 180 (59) | 387 (54) |
1 approved by 5 research ethics committees in Switzerland and Canada [1].
2 includes 37 RCTs and 13 non-RCTs with industry funding but no industry involvement, i. e. in study planning, management or analysis of data.
All percentages (in brackets) refer to the total number of the respective column
Abbreviations: NPSs, non-randomised prospective studies; RCTs, randomised controlled trials; IQR, interquartile range.