SPIRIT component | Belonging to SPIRIT Item Number | 2012 | 2016 | Absolute increase | ||||
---|---|---|---|---|---|---|---|---|
Industry sponsorship (n=49) | Non-industry sponsorship (n=54) | Total 2012 (n=103) | Industry sponsorship (n=62) | Non-industry sponsorship (n=46) | Total 2016 (n=108) | |||
Basic study design in title | 1 | 31 (63.3%) | 9 (16.7%) | 40 (38.8%) | 53 (85.5%) | 24 (52.2%) | 77 (71.3%) | 32.5% |
Name and contact details of sponsor | 5b | 12 (24.5%) | 16 (29.6%) | 28 (27.2%) | 31 (50.0%) | 31 (67.4%) | 62 (57.4%) | 30.2% |
Steering Committee General Membership and Role | 5d | 35 (71.4%) | 45 (83.3%) | 81 (77.7%) | 56 (90.3%) | 39 (84.8%) | 73 (98.0%) | 20.3% |
Of which not applicable | 30 (61.2%) | 29 (53.7%) | 59 (57.3%) | 46 (74.2%) | 24 (52.2%) | 70 (64.8%) | ||
Research question described and justified | 6a | 11 (22.5%) | 9 (16.7%) 2NA | 20 (19.4%) | 35 (56.5%) | 13 (28.3%) | 48 (44.4%) | 25.0% |
Strategies to improve or monitoring of adherence | 11c | 33 (67.4%) | 34 (63.0%) | 67 (65.1%) | 57 (91.9%) | 40 (87.0%) | 97 (89.8%) | 24.7% |
Of which not applicable | 9 (18.4%) | 25 (46.3%) | 34 (33.0%) | 23 (37.1%) | 28 (60.9%) | 51 (41.2%) | ||
Expected recruitment rate | 15 | 7 (14.3%) | 15 (14.3%) | 22 (21.4%) | 20 (32.3%) | 25 (45.4%) | 45 (41.7%) | 20.3% |
Method for generation of random sequence | 16a | 21 (42.8%) | 29 (53.7%) | 50 (48.5%) | 51 (82.3%) | 30 (65.2%) | 81 (75.0%) | 26.5% |
Strategies to promote participant retention and complete follow-up | 18b | 9 (18.4%) | 20 (38.0%) | 29 (28.4%) | 38 (61.3%) | 16 (34.8%) | 54 (50.0%) | 21.6% |
Of which not applicable | 2 (4.1%) | 2 (3.7%) | 4 (3.9%) | - | - | - | ||
Data entry and coding | 19 | 11 (22.5%) | 9 (15.5%) | 20 (18.7%) | 49 (79.0%) | 20 (43.5%) | 69 (63.9%) | 45.2% |
Process for making amendments described | 25 | 27 (55.1%) | 8 (14.8%) | 35 (34.0%) | 50 (80.7%) | 21 (45.7%) | 71 (65.7%) | 31.7% |
Declaration of Interests | 28 | 8 (16.3%) | 4 (7.4%) | 12 (11.7%) | 60 (96.8%) | 10 (21.7%) | 70 (64.8%) | 53.1% |
Ancillary and post-trial care | 30 | 4 (8.2%) | 8 (14.8%) | 12 (11.7%) | 29 (46.8%) | 31 (67.4%) | 60 (55.6%) | 43.9% |