IDIBELL and linked hospitals (Bellvitge University Hospital and Duran i Reynals Hospital-Catalan Institute of Oncology) already had an infrastructure and support services for clinical trials that had allowed them to be a reference for private developers. They had also made possible to launch clinical trials with no commercial interest thanks to the aids of competitive and other public announcements. As a result of this strategy, IDIBELL launched a unit to provide support services to these projects in line with IDIBELL's Statistical Assessment Service.

But so far, support for clinical research groups was provided by each actor and there wasn't a comprehensive and coordinated model. There wasn't a single point to conduct clinical research groups for advice and support. This fact has been a limitation relevant to clinical trials with no commercial interest, especially those in which the promoter was a IDIBELL's researcher.

For this reason, IDIBELL, Bellvitge Hospital and Catalan Institute of Oncology, have decided to create a global structure that would incorporate and coordinate support structures that already existed. The decision was also taken when the Spanish Government's Instituto de Salud Carlos III created the Consortium for Biomedical Research Support Network (CAIBER).

CAIBER is specifically intended to strengthen and support the cooperative clinical research, for the development of clinical trials, especially those who have no commercial interest. Thus was born the Central Clinical Research Unit in Clinical Trials (UCICEC) of IDIBELL, part of CAIBER.

The unit aims to consolidate the trials with no commercial interest, enhance private developer clinical trials (eg. pharmaceutical or health technology producer) and the pursuit of excellence and leadership in both fields.

Objectives

The unit aims to provide support for clinical research groups at the Bellvitge University Hospital and in Duran i Reynals Hospital-Catalan Institute of Oncology for conducting clinical trials, especially those that have no commercial interest.

Scope

UCICEC's scope are clinical drug trials, medical devices and other therapeutic interventions studies. The project also include randomized clinical trials of intervention for diagnostic, preventive or service purposes.

Advice and support

UCICEC offers advice and support on issues related to methods and statistical, regulatory and procedural aspects, economic aspects and medication management, execution tests, data management and results analysis. The advice and support includes very specialized aspects which are responsibility of the promoter such as those related to documenting, archiving, monitoring and follow-up clinical trials.

The project is designed to provide central services to researchers or groups who want to develop a clinical trial.

UCICEC support depend on the resources available and developers need to ensure the economic viability of clinical trials.

UCICEC integrate ICO and HUB clinical trials' units, it has specific personnel and coordinates with the Clinical Research Ethics Committee. The approach is an integrated model that incorporates IDIBELL's economic and administrative units and HUB and ICO pharmacy services, and coordinates the service of clinical pharmacology and other actors engaged in supporting clinical research in the HUB and ICO.

UCICEC's support depends on the resources available and the developers have to ensure the viability of providing clinical trial.

Support services for CAIBER clinical trials included in its clinical research planning (through annual intramural calls) will be provided with the resources financed by the consortium.

Support to independent clinical trials not financed by the CAIBER Consortium will be provided through the resources obtained by the principal investigator in public calls. This support will be formalized in an agreement to provide services subject to internal rates. Private developers could formalize agreements based on external rates.

Priorities

The advice and support will be prioritized based on the following:

Clinical trials with no commercial interest
Clinical trials in which the promoter is a clinical research group
Multi-center clinical trials.

The UCICEC CAIBER stimulate the incorporation of clinical trials sponsored by research groups and clinical HUB ICO and also their participation in clinical trials managed or promoted by the CAIBER.

The UCICEC give top priority to these trials, particularly those that use resources financed by CAIBER.