Table 4.
Items of primary concern
| Category | Number of trials | % |
|---|---|---|
|
1. Malignancy/others |
|
|
| Malignancy |
1,327 |
47.8 |
| Others |
1,452 |
52.2 |
|
2. Genomic information |
|
|
| Used |
230 |
8.3 |
| Not used |
2,549 |
91.7 |
|
3. Confirmatory/exploratory |
|
|
| Confirmatory |
1,010 |
36.3 |
| Exploratory |
762 |
27.4 |
| Missing data |
1,007 |
36.2 |
|
4. Explanatory/pragmatic |
|
|
| Explanatory |
326 |
11.7 |
| Pragmatic |
1,081 |
38.9 |
| Missing data |
1,372 |
49.4 |
|
5. Basic design |
|
|
| Parallel |
1,334 |
48.0 |
| Crossover |
135 |
4.9 |
| Factorial |
17 |
0.6 |
| Single-arm |
1,289 |
46.4 |
| Expanded access |
4 |
0.1 |
|
6. Randomization |
|
|
| Randomized |
1,346 |
48.4 |
| Non-randomized |
1,433 |
51.6 |
|
7. Blinding |
|
|
| Open |
2,181 |
78.5 |
| Assessor blinded |
298 |
10.7 |
| Single-blind (participants) |
87 |
3.1 |
| Single-blind (investigators and assessors) |
33 |
1.2 |
| Double-blind |
180 |
6.5 |
|
8. Control |
|
|
| Placebo |
187 |
6.7 |
| No treatment |
249 |
9.0 |
| Active |
959 |
34.5 |
| Dose comparison |
70 |
2.5 |
| Historical |
281 |
10.1 |
| Uncontrolled |
1,033 |
37.2 |
|
9. Number of arms |
|
|
| 1 |
1,289 |
46.4 |
| 2 |
1,282 |
46.1 |
| 3 |
145 |
5.2 |
| >4 |
63 |
2.3 |
|
10. Type of interventiona |
|
|
| Medicine |
2,074 |
74.6 |
| Vaccine |
112 |
4.0 |
| Genetic |
16 |
0.6 |
| Food |
75 |
2.7 |
| Device, equipment |
273 |
9.8 |
| Behavior, custom |
133 |
4.8 |
| Maneuver |
445 |
16.0 |
| Others |
0 |
0.0 |
|
11. Target sample size |
|
|
| 1 to 10 |
210 |
7.6 |
| 11 to 100 |
1,781 |
64.1 |
| 101 to 1,000 |
725 |
26.1 |
| 1001 to 1,0000 |
58 |
2.1 |
| >10,000 |
5 |
0.2 |
|
12. Trial period (months)b |
|
|
| 0 to 6 |
138 |
5.0 |
| 7 to 12 |
180 |
6.5 |
| 13 to 36 |
1,057 |
38.0 |
| 37 to 60 |
611 |
22.0 |
| >60 |
428 |
15.4 |
| Missing data |
365 |
13.1 |
|
13. Report of resultsc |
|
|
| Unpublished |
2,501 |
90.0 |
| Published |
136 |
4.9 |
| Partially published |
142 |
5.1 |
|
14. Disclosure of trial before/after trial startd |
|
|
| Disclosure first |
303 |
10.9 |
| Trial start first |
2,476 |
89.1 |
| Total | 2,779 | 100 |
aValues within this category are not mutually exclusive (total number: >2,779); bperiod between trial start date and date of last patient’s final visit; c'published’: the final trial results were published regardless of the kind of publication form (journals, academic conferences, webpages, and so on), 'partially published’: only the results of interim analyses were published; ddate of first enrollment was taken as the trial start date.