From: Publication of clinical trials on medicinal products: follow-up on trials authorized in Hungary
Industry-initiated clinical trials (n = 320) % | Investigator-initiated clinical trials (n = 9) % | |
---|---|---|
Financial background | ||
Founded by the industry | 96.88 | 11.11 |
Founded by non-industry | 0 | 55.55 |
No information available | 3.13 | 33.33 |
Trial design | ||
RCT | 79.69 | 88.88 |
Non-RCT | 16.88 | 11.11 |
No information available | 2.81 | 0 |
Blinding | ||
Double-blind | 62.19 | 44.44 |
Single-blind | 1.25 | 0 |
Open-label | 21.88 | 44.44 |
Not clear | 14.69 | 11.11 |
Collaboration | ||
National | 1.88 | 44.44 |
International (only EEA) | 88.75 | 33.33 |
International (within and outside the EEA) | 9.375 | 22.22 |
Trial scope | ||
Safety and efficacy | 93.75 | 55.55 |
Safety | 5 | 0 |
Efficacy | 1.25 | 33.33 |
None | 0 | 11.11 |
Trial phase | ||
Phase I | 1.5625 | 0 |
Phase II | 38.75 | 0 |
Phase III | 52.8125 | 55.55 |
Phase IV | 4.0625 | 22.22 |
Not mentioned/More phases | 2.8125 | 22.22 |
Data monitoring committee | ||
Yes | 55.31 | 33.33 |
No | 44.69 | 66.66 |
Availability of study results | ||
Results posted in EU CTR | 73.125 | 11.11 |
Results published as full scientific publication | 62.8125 | 55.55 |
Time to publication (months; mean [SD]) | 21.70 [16,82] | 18.33 [3,77] |
Impact on the scientific reputation of the authorizing country | ||
Publication with at least one Hungarian author | 12.1875 | 33.33 |
Publication mentioning Hungarian participant(s) | 27.5 | 44.44 |