Table 2.
N | % Terminated | p Value‡ | % Poor | p Value‡ | ||
Year | 2006–2007 | 1078 | 7.0 | <0.001 | 42.3 | <0.001 |
2008–2009 | 1893 | 6.6 | 43.0 | |||
2010–2011 | 1955 | 6.0 | 43.3 | |||
2012–2013 | 1596 | 4.9 | 32.8 | |||
2014–2015 | 624 | 4.2 | 44.2 | |||
Facility location* | Africa | 32 | 3.2 | <0.001 | 100.0 | <0.001 |
Americas | 3769 | 14.0 | 46.3 | |||
Americas Asia Europe | 129 | 13.2 | 17.6 | |||
Americas Asia Europe Oceania | 89 | 7.9 | 14.3 | |||
Americas Europe | 256 | 18.0 | 34.7 | |||
Asia | 1079 | 5.6 | 33.3 | |||
Europe | 2454 | 9.6 | 40.4 | |||
Oceania | 71 | 18.3 | 30.8 | |||
Other | 374 | 4.2 | 50.8 | |||
Missing | 647 | 5.9 | 23.7 | |||
Phase | Phase 0 | 81 | 9.9 | <0.001 | 32.9 | 0.012 |
Phase 1 | 736 | 11.3 | 29.8 | |||
Phase 1/Phase 2 | 415 | 15.1 | 36.5 | |||
Phase 2 | 1542 | 11.7 | 44.4 | |||
Phase 2/Phase 3 | 231 | 13.2 | 36.9 | |||
Phase 3 | 1419 | 11.0 | 51.5 | |||
Phase 4 | 2997 | 8.2 | 46.6 | |||
NA | 1479 | 8.6 | 14.3 | |||
Intervention type | Behavioural | 603 | 4.5 | <0.001 | 1.8 | <0.001 |
Biological | 294 | 10.2 | 33.3 | |||
Device | 1679 | 11.9 | 42.7 | |||
Dietary supplement | 266 | 5.3 | 50.0 | |||
Drug | 4309 | 13.4 | 39.8 | |||
Genetic | 26 | 7.7 | 0.0 | |||
Procedure | 44 | 13.6 | 45.1 | |||
Radiation | 784 | 10.5 | 83.3 | |||
Other | 895 | 5.4 | 47.9 | |||
No of arms | 1 | 2474 | 11.2 | 0.004 | 42.0 | <0.001 |
2 | 4725 | 11.7 | 43.5 | |||
>2 | 1466 | 8.5 | 29.8 | |||
Missing | 235 | 13.6 | 34.4 | |||
Primary purpose | Basic science | 250 | 4.8 | <0.001 | 25.0 | 0.002 |
Diagnostic | 491 | 11.0 | 50.0 | |||
Health services research | 197 | 4.1 | 37.5 | |||
Prevention | 1008 | 9.5 | 37.5 | |||
Screening | 46 | 4.3 | 0.0 | |||
Supportive care | 280 | 10.3 | 75.0 | |||
Treatment | 6264 | 12.1 | 39.7 | |||
Missing | 364 | 8.0 | 48.3 | |||
Allocation | Non-randomised | 1052 | 11.0 | 0.986 | 31.0 | 0.155 |
Randomised | 6039 | 11.0 | 41.9 | |||
Missing | 1809 | 11.2 | 44.1 | |||
Endpoint classification | Bioavailability | 18 | 5.6 | <0.001 | 0.0 | 0.155 |
Bioequivalence | 38 | 7.9 | 66.7 | |||
Efficacy | 2668 | 10.7 | 47.2 | |||
Pharmacodynamics | 121 | 11.6 | 35.7 | |||
Pharmacokinetics | 124 | 4.0 | 0.0 | |||
Pharmacokinetics/Dynamics | 111 | 12.6 | 28.6 | |||
Safety | 625 | 9.1 | 36.8 | |||
Safety/Efficacy | 3811 | 12.8 | 37.2 | |||
Missing | 1384 | 8.5 | 47.5 | |||
Masking | Double-blind | 2775 | 12.6 | <0.001 | 36.7 | 0.119 |
Open-label | 4798 | 11.2 | 43.1 | |||
Single-blind | 1287 | 7.1 | 46.2 | |||
Missing | 40 | 15.0 | 33.3 | |||
Intervention model | Crossover | 713 | 7.4 | 0.009 | 39.6 | 0.148 |
Factorial | 156 | 8.3 | 38.5 | |||
Parallel | 5246 | 11.4 | 41.5 | |||
Single group | 2727 | 11.4 | 40.8 | |||
Missing | 58 | 15.5 | 33.3 | |||
No of enrolled | (0, 100] | 5521 | 14.0 | <0.001 | 45.3 | <0.001 |
(100, 1000] | 2832 | 6.3 | 27.4 | |||
(1000, 20 000] | 467 | 5.6 | 10.7 | |||
>20 000 | 53 | 3.8 | 0.0 | |||
Missing | 27 | 19.2 | 40.0 | |||
No of facilities (per study) | 1 | 4934 | 10.3 | <0.001 | 44.4 | <0.001 |
(1, 10] | 1876 | 14.4 | 44.1 | |||
(10, 50] | 1047 | 11.5 | 35.0 | |||
(50, 100] | 204 | 14.2 | 17.2 | |||
>100 | 191 | 9.4 | 16.7 | |||
Missing | 648 | 5.9 | 23.7 | |||
No of conditions (per study) | 1 | 6703 | 11.8 | 0.068 | 41.3 | 0.228 |
2 | 1584 | 8.2 | 44.0 | |||
>2 | 613 | 13.8 | 32.9 | |||
Conditions† | Acute coronary syndrome | 205 | 12.2 | - | 48.3 | - |
Atrial fibrillation | 380 | 13.4 | 37.2 | |||
Cardiovascular diseases | 481 | 5.4 | 34.6 | |||
Coronary artery disease | 609 | 8.7 | 50.9 | |||
Coronary disease | 341 | 10.0 | 32.3 | |||
Heart failure | 644 | 13.8 | 53.9 | |||
Hypertension | 901 | 10.2 | 29.3 | |||
Multiple myeloma | 620 | 15.8 | 42.9 | |||
Myocardial infarction | 216 | 9.7 | 38.2 | |||
Myocardial ischaemia | 414 | 10.9 | 20.0 | |||
Stroke | 477 | 10.9 | 34.6 | |||
Overall | 8900 | 11.1 | 41.1 |
*Facility location describes the study-level location of enrolling sites. It results in a single continent for single-centre trials and multicentre multinational trials and in a combination of continents for intercontinental trials.
†The number of MeSH conditions sums to 13 501 across the 8900 closed trials. Only the conditions exceeding an absolute frequency of 200 are listed.
‡χ2 or Fisher test p values.