Table 1. Characteristics of placebo randomized controlled trials registered in ClinicalTrials.gov (1999–2015).
| N | % | |
|---|---|---|
| TOTAL NUMBER OF TRIALS | 146 | 100.0 |
| NEONATES STUDIED | ||
| Preterm | 70 | 47.9 |
| Term | 35 | 24.0 |
| Preterm and Term | 41 | 28.1 |
| NUMBER OF PATIENTS PLANNED | ||
| 0–50 | 35 | 24.6 |
| 51 to 100 | 42 | 29.5 |
| >100 | 65 | 45.7 |
| unknown | 4 | 0.2 |
| SPONSOR (N) | ||
| Industry | 21 | 14.4 |
| Government* | 22 | 15.0 |
| Non-federal/Non-profit1 | 81 | 55.5 |
| Government+Industry | 2 | 1.4 |
| Non-federal/Non-profit+ Industry | 9 | 6.2 |
| Non-federal/Non-profit+Government | 10 | 6.8 |
| Non-federal+Industry+Governement | 1 | 0.7 |
| STUDY PHASES | ||
| Phases 1 and 1/2 | 21 | 14.4 |
| Phases 2 and 2/3 | 57 | 39.0 |
| Phase 3 | 40 | 27.4 |
| Phase 4 | 28 | 19.2 |
| BLINDING | ||
| Blinded | 144 | 98.6 |
| Open label | 2 | 1.4 |
| LOCATION (N) | ||
| SINGLE CENTER | 81 | 55.5 |
| Africa | 2 | 2.5 |
| Middle East Asia | 22 | 27.2 |
| Europe | 18 | 22.2 |
| North America | 35 | 43.2 |
| South America | 4 | 4.9 |
| Oceania | 0 | 0 |
| MULTICENTER NATIONAL TRIALS | 43 | 29.5 |
| Europa | 4 | 9.3 |
| North America | 38 | 88.4 |
| Asia | 1 | 2.3 |
| MULTICENTER INTERNATIONAL TRIALS | 10 | 6.8 |
| Africa | 1 | 10.0 |
| Middle East Asia | 3 | 30.0 |
| Europe | 10 | 100.0 |
| North America | 5 | 50.0 |
| South America | 1 | 10.0 |
| Oceania | 2 | 20.0 |
| UNKNOWN | 12 | 8.2 |
| RECRUITMENT STATUS2 | ||
| Open—recruiting | 21 | 14.4 |
| Open—not recruiting | 15 | 10.3 |
| Completed | 91 | 62.3 |
| Unknown | 19 | 13.0 |
| LENGHT OF STUDY (as planned—years) | ||
| <1 | 40 | 27.4 |
| 1–2 | 56 | 38.4 |
| 3–4 | 25 | 17.1 |
| >4 | 25 | 17.1 |
| Unknown | 0 | 0.0 |
| PUBLICATION*2 | ||
| Yes | 58 | 39.7 |
| Patients reported in the publication versus planned in the trial | ||
| ± 10% of planned | 35 | 24.0 |
| More than 10% higher | 15 | 10.2 |
| More than 10% lower | 8 | 5.5 |
| No | 88 | 60.3 |
* GOVERNMENT = all the Governmental Institutions + US Federal Agency + NIH (National Institute of Health)
1 NON-FEDERAL = University+ Organization+ Hospital+ Clinical Research Network
2 Updated in December 2017