Introduction
Methods
-
Research protocol variables: study design (interventional, observational, qualitative study, and others), funding source (external or internal grant (grants from IDIAPJGol or ICS), private funding, no funding), COVID-19 study objective topic (epidemiology, pharmacotherapy, diagnosis and seroprevalence, and population impact).
-
Principal Investigator (PI) characteristics: gender, professional category, PhD degree, membership to a research group.
-
Outcomes of the EC process: result of the evaluation (approval, modification required, denied) and time until approval.
Statistical analysis
Results
2019 | 2020 | 2021 | TOTAL | |
---|---|---|---|---|
N (%) | 223 (29.7) | 235 (31.3) | 293 (39.0) | 751 (100.0) |
Study design | ||||
Interventional study | 42 (18.8) | 43 (18.3) | 39 (13.3) | 124 (16.5) |
Observational study | 155 (69.5) | 161 (68.5) | 197 (67.2) | 513 (68.3) |
Qualitative study | 18 (8.1) | 18 (7.7) | 40 (13.7) | 76 (10.1) |
Othersa | 8 (3.6) | 13 (5.5) | 17 (5.8) | 38 (5.1) |
Funding | ||||
External/Public grant | 26 (11.7) | 39 (16.6) | 52 (17.7) | 117 (15.6) |
Internal grant | 39 (17.5) | 14 (6.0) | 9 (3.1) | 62 (8.3) |
Private funding | 36 (16.1) | 34 (14.5) | 68 (23.2) | 138 (18.4) |
No funding | 122 (54.7) | 148 (63) | 164 (56) | 434 (57.8) |
PI characteristics | ||||
Gender (Female) | 156 (70.0) | 152 (64.7) | 183 (62.5) | 491 (65.4) |
Holds a PhD degree (yes) | 78 (34.5) | 90 (38.3) | 104 (35.5) | 272 (36.2) |
Member of a research group (yes) | 56 (24.8) | 71 (30.2) | 76 (25.9) | 203 (27) |
Professionals | ||||
General Practitioners (GP) | 104 (46.6) | 106 (45.1) | 120 (41.0) | 330 (43.9) |
Physicians other than GP | 27 (12.1) | 34 (14.5) | 36 (12.3) | 97 (12.9) |
Pediatricians | 7 (3.1) | 10 (4.3) | 4 (1.4) | 21 (2.8) |
Physicians (Gynecologist) | 2 (0.9) | 2 (0.9) | 4 (1.4) | 8 (1.1) |
Nurse | 49 (22.0) | 47 (20.0) | 63 (21.5) | 159 (21.2) |
Other health professionals | 18 (8.1) | 10 (4.3) | 14 (4.8) | 42 (5.6) |
Pharmacists | 8 (3.6) | 7 (3.0) | 11 (3.8) | 26 (3.5) |
Biostatisticians/IT | 0 (0.0) | 0 (0.0) | 5 (1.7) | 5 (0.7) |
Others | 3 (1.3) | 3 (1.3) | 11 (3.8) | 17 (2.3) |
Unknown | 5 (2.2) | 16 (6.8) | 25 (8.5) | 46 (6.1) |
Number of sessions held | 12 | 25 | 18 | 55 |
EC Results | ||||
Approval | 185 (83.0) | 188 (80.0) | 241 (82.3) | 614 (81.6) |
Days until approval | ||||
0 | 47 (25.4) | 55 (29.3) | 66 (27.4) | 168 (27.4) |
1–30 | 41 (22.2) | 54 (28.7) | 73 (30.3) | 168 (27.4) |
31–90 | 51 (27.6) | 42 (22.3) | 75 (31.1) | 168 (27.4) |
91–180 | 30 (16.2) | 28 (14.9) | 25 (10.4) | 83 (13.5) |
> 6 months | 16 (8.6) | 9 (4.8) | 2 (0.8) | 27 (4.4) |
Modification required | 38 (17.0) | 44 (18.7) | 51 (17.4) | 133 (17.8) |
Withdrawn | 0 (0.0) | 3 (1.3) | 0 (0.0) | 3 (0.4) |
Denied | 0 (0.0) | 0 (0.0) | 1 (0.3) | 1 (0.1) |
Days to be approved (mean, SD) | 55 (73.0) | 41.5 (65.4) | 34.9 (40.6) | 42.9 (60.2) |
Covid-19 study objective topic | 86 (41.3) | 122 (58.7) | 208 (100.0) | |
Epidemiology | 26 (30.2) | 24 (19.7) | 50 (24.0) | |
Pharmacological treatment | 9 (10.5) | 37 (30.3) | 46 (22.1) | |
Diagnoses tests | 24 (27.9) | 17 (13.9) | 41 (19.7) | |
Population impact of COVID-19 | 27 (31.4) | 44 (36.1) | 71 (34.1) |
Total protocols 469 | COVID-19 | No COVID-19 | p value |
---|---|---|---|
N (%) | 208 (44.3) | 261 (55.7) | 0.016 |
Study design | |||
Interventional study | 17 (8.2) | 48 (18.4) | 0.001 |
Observational study | 162 (77.9) | 161 (61.7) | 0.000 |
Qualitative study | 18 (8.7) | 34 (13.0) | 0.134 |
Othersa | 11 (5.3) | 18 (6.9) | 0.473 |
Funding | |||
External/Public grant | 47 (22.6) | 37 (14.2) | 0.018 |
Internal grant | 7 (3.4) | 12 (4.6) | 0.501 |
Private funding | 33 (15.9) | 64 (24.5) | 0.021 |
No funding | 121 (58.2) | 148 (56.7) | 0.749 |
PI characteristics | |||
Gender (Female) | 122 (58.7) | 174 (66.7) | 0.002 |
Holds a PhD degree (yes) | 86 (41.3) | 88 (33.7) | 0.019 |
Research group membership (yes) | 74 (35.6) | 61 (23.4) | 0.004 |
Professionals | |||
General Practitioners (GP) | 100 (48.1) | 91 (34.9) | 0.004 |
Physicians other than GP | 34 (16.3) | 33 (12.6) | 0.255 |
Pediatricians | 7 (3.4) | 6 (2.3) | 0.485 |
Physicians (Gynecologist) | 0 (0.0) | 6 (2.3) | 0.008 |
Nurse | 29 (13.9) | 66 (25.3) | 0.002 |
Other health professionals | 10 (4.8) | 14 (5.4) | 0.786 |
Pharmacists | 6 (2.9) | 10 (3.8) | 0.575 |
Biostatisticians/IT | 2 (1.0) | 3 (1.1) | 0.844 |
Others | 4 (1.9) | 10 (3.8) | 0.228 |
Unknown | 16 (7.7) | 22 (8.4) | 0.771 |
EC Results | |||
Approval | 175 (84.1) | 209 (80.1 | 0.257 |
Days until approval | |||
0 | 46 (26.3) | 57 (27.3) | 0.828 |
1–30 | 16 (9.1) | 54 (25.8) | 0.009 |
31–90 | 67 (38.3) | 65 (31.1) | 0.197 |
91–180 | 44 (25.1) | 28 (13.4) | 0.192 |
> 6 months | 2 (1.1) | 5 (2.4) | 0.362 |
Modification required | 32 (15.4) | 49 (18.8) | 0.335 |
Withdrawn | 1 (0.5) | 2 (0.8) | 0.696 |
Denied | 0 (0.0) | 1 (0.4) | 0.279 |
Days to be approved (mean, SD) | 33.3 (45.0) | 40.1 (52.1) | 0.101 |