AICRO (Associazione Italiana Contract Research Organization) established a working group to define criteria and guidelines for healthcare structures that wish to create an infrastructure supporting clinical trials conduction and all the aspects related to clinical research in general.
The working group that drafted these criteria and guidelines includes some of the most important centers, institutions, clinical hospitals and patients associations active in the field of clinical research: AICRO; Agenzia Italiana del farmaco (AIFA); Azienda Ospedaliera (A.O.) Universitaria di Parma; A.O. Universitaria Pisana; Centro Diagnostico Italiano (CDI); Consorzio per Valutazioni Biologiche e Famacologiche (CVBF); European Patients’ Academy on Therapeutic Innovation (EUPATI); Ospedale Papa Giovanni XXIII di Bergamo; Ospedale San Raffaele di Milano; Fondazione Policlinico Gemelli di Roma; Policlinico Umberto I di Roma; Università degli Studi di Roma Tor Vergata.
The final achievement of this collaborative activity is the release of a White Paper defining a Clinical Trial Center (CTC), giving recommendations for the setup of a CTC and the essential services to be provided.
According to the White Paper, a CTC is “an organisational structure which operates as a centre of coordination and control within a Healthcare Structure, supporting one or more trial units; it can act as a central body for the execution of clinical studies and can fulfil the standards required by the external stakeholders (Sponsors, CROs, Associations Regulatory Agencies, etc.) in an effective and efficient manner. The Clinical Trial Centre may also be the Sponsor of clinical studies (e.g.: in the case of non-profit/academic studies), provided it has the appropriate clinical research professionals (such as quality assurance managers, statisticians, monitors, data managers, etc.) available”.
During the start-up phase, a CTC should act as a link between all the actors involved in the clinical research and work directly with all internal stakeholders (Ethics Committee, Administration, Investigators, Labs). A CTC should provide accurate study management in the clinical trial conduction promoting, at the same time, high quality standards at the site (through a quality management system and the predisposition of Standard Operating Procedures – SOPs). Moreover, a CTC should provide adequate Good Clinical Practice (GCP) training courses for the site personnel.
Finally, an effective internal and external communication plan has to be foreseen to ensure the achievement of the long-term objectives as well as collaborations and participations in national and international networks have to be promoted to pursue excellence in the clinical research field.
The AICRO White Paper is available at this link.