Clinical research and burnout syndrome in Italy - only a physicians' affair?

Background: The burnout phenomenon has been extensively investigated among health care professionals, particularly focusing on physicians and nurses. However, literature concerning burnout in clinical research is poor and often neglects the other professional categories involved.

Methods: In March 2019, all members of Italian Group of Clinical Research Coordinator were invited to participate to a web survey, consisting of three sections: general information and workload; Maslach Burnout Inventory (MBI) test; subjective perception of oneself's work stress and possible causes.

[Clinical research: enough players to get out there?].

Despite the presence of experienced and multidisciplinary staff is now essential due to the increasing complexity of clinical research, many national collective health contracts do not yet contemplate the new professional figures. This instability risks causing an alarming professional gap, especially for non-profit clinical research. For this reason, we would try to evaluate the extent to which the problem is widespread among Italian clinical research coordinators, verifying how much the Italian institutes have permanently integrated this professional figure into organic plant, through stable and specific employment contracts.

Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Local and Contralateral Recurrence in Breast Intraepithelial Neoplasia.

Purpose: Tamoxifen administered for 5 years at 20 mg/d is effective in breast cancer treatment and prevention, but toxicity has limited its broad use. Biomarker trials showed that 5 mg/d is not inferior to 20 mg/d in decreasing breast cancer proliferation. We hypothesized that a lower dose given for a shorter period could be as effective in preventing recurrence from breast intraepithelial neoplasia but have a lower toxicity than the standard dose.

[Clinical research coordinators: a crucial resource.].

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 qualified 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 figure able to manage the workflow required, placing himself as a reference for the coordination of the various activities and professional figures involved. The literature has widely demonstrated how the presence of this professional figure 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.