Clinical Research
Clinical Research at the University Hospital Reina Sofia
Clinical trials allow the experimental evaluation in terms of efficacy and safety, of a product, drug, diagnostic or therapeutic technique in humans.
Patients treated at the University Hospital Reina Sofia and in other hospitals of the province pertaining to the Andalusian Health System (SAS) are potential candidates to participate in the different clinical trials performed at their facilities with the main objective of improving their treatments.
The following figures present the number of active clinical trials by Service and by Phase at a given point in time, in December 2020.
IMIBIC has a Clinical Trial Management System which allows real-time monitoring of data and indicators related with the development of clinical trials throughout their different stages, e.g. time needed for contract signature, inclusion of patients or recruitment. It also allows the comparison of the indicators with those published by the pharmaceutical industry at national level.
| INDICATORS | IMIBIC’s results | National results |
|---|---|---|
| Time from Ethics Committee Submit to First Patient Included *days | 145 | 225 |
| Time from Ethics Committee submit to fully signed contract *days | 79,5 | 136 |
| Time from fully signed contract to First Patient Included. *days | 44,5 | 71 |
| Time from Ethics Committee submit to local Ethics Committee Approval *days | 29 | 55 |
| Recruitment rate *% | 99% | 101% |
| Recruitment speed *patients/month | 1,32 | 1,26 |