Table 2 Summary of the characteristics of the clinical trials monitored in each quarter
From: The clinical trial activation process: a case study of an Italian public hospital
November 19–February 20 | May 20–August 20 | September 20–December 20 | January 21–April 21 | May 21–August 21 | September 21–December 21 | January 22–April 22 | May 22- Aug 22 | Tot | |
|---|---|---|---|---|---|---|---|---|---|
Trial design | |||||||||
Interventional | 11 | 12 | 14 | 13 | 11 | 14 | 15 | 8 | 98 |
Observational | 15 | 18 | 19 | 24 | 22 | 47 | 34 | 21 | 200 |
Trial nature | |||||||||
Industrial sponsored | 5 | 11 | 7 | 11 | 8 | 6 | 3 | 5 | 56 |
Institutional/investigator initiated | 21 | 19 | 26 | 26 | 25 | 55 | 46 | 24 | 242 |
Agreement | |||||||||
Yes | 12 | 13 | 13 | 18 | 12 | 16 | 8 | 8 | 100 |
No | 14 | 17 | 20 | 19 | 21 | 45 | 41 | 21 | 198 |
Tot number trial considered | 26 | 30 | 33 | 37 | 33 | 61 | 49 | 29 | 298 |
Trial activated | 24 | 30 | 30 | 34 | 33 | 58 | 46 | 27 | 282 |
Number and reasons for non-activated trails | 2 not completed approval process at local EC | 2 not completed approval process at local EC; 1 negative opinion from the national competent authority | 2 not completed approval process at local EC; 1 negative opinion from the national competent authority | 3 not completed approval process at local EC | 3 not completed approval process at local EC | 1 not completed approval process at local EC; 1 withdrawn by the sponsor | |||