The increasing complexity that characterizes the world of clinical trials, both in terms of procedures and bureaucracy, has made it necessary to create dedicated infrastructures composed of experienced and qualifed personnel, who constantly work to ensure high ethical and qualitative standards. A key role in these infrastructures is played by the clinical research coordinator, a key fgure able to manage the work?ow required, placing himself as a reference for the coordination of the various activities and professional fgures involved. The literature has widely demonstrated how the presence of this professional fgure is a valid contribution both from a documentary and administrative point of view as well as a crucial resource for what concerns the indicators of ethics and quality of research. Despite that, there is no yet an institutional recognition of the professional fgure, neither a specifc economical agreement within the National Health System. The lack of institutional recognition is causing a worrying phenomenon of migration of qualifed personnel towards contract research organizations and pharmaceutical companies. That could be detrimental to the competitiveness of Italian clinical research and hinder the possibility of offering innovative experiments therapies to patients, with serious ethical consequences.
Clinical research coordinators: A crucial resource
Cagnazzo C.;
2019-01-01
Abstract
The increasing complexity that characterizes the world of clinical trials, both in terms of procedures and bureaucracy, has made it necessary to create dedicated infrastructures composed of experienced and qualifed personnel, who constantly work to ensure high ethical and qualitative standards. A key role in these infrastructures is played by the clinical research coordinator, a key fgure able to manage the work?ow required, placing himself as a reference for the coordination of the various activities and professional fgures involved. The literature has widely demonstrated how the presence of this professional fgure is a valid contribution both from a documentary and administrative point of view as well as a crucial resource for what concerns the indicators of ethics and quality of research. Despite that, there is no yet an institutional recognition of the professional fgure, neither a specifc economical agreement within the National Health System. The lack of institutional recognition is causing a worrying phenomenon of migration of qualifed personnel towards contract research organizations and pharmaceutical companies. That could be detrimental to the competitiveness of Italian clinical research and hinder the possibility of offering innovative experiments therapies to patients, with serious ethical consequences.
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