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. RESULTS: The majority of respondents felt a form of distress. The main source was contract type (31.2%), followed by workload (20.5%) and lack of skills recognition (17.8%). Results from MBI test confirmed the interviewees' subjective perception: an intermediate level of emotional exhaustion (19.1 points) and a very high sense of reduced professional achievement (26.8 points) were observed. Both depersonalization and sense of reduced professional achievement showed weak to moderate correlations with emotional exhaustion. Emotional exhaustion was associated with contract type with high significance. CONCLUSION: It is necessary to act on those qualitative factors that are greatly increasing the level of perceived stress, jeopardizing the quality of clinical research coordinators work and significantly amplifying the phenomenon of migration towards the private sector.

[Clinical research: enough players to get out there?] / Ricerca clinica: abbastanza giocatori per vincere la partita?

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. In November 2016, when the Italian Government has declared for the first time its intention to prevent further renewal of contracts with atypical employment, we conducted a survey with the intent of mapping the extent of the contractual issues related to the figure of the clinical research coordinator. Two years later, we repeated the survey to see if something was changed and if it was any improvement in the employment situation. In November 2016, only a small fraction of the respondents (13.8%) was hired with a permanent contract, while the majority (73.2%) were employed with an atypical one. Regarding the impossibility to renew the atypical contracts due to the new Government provisions starting from January 2017: the 67.5% of the respondents stated that the issue would directly affect him. Two years later, the situation looks even worse: only the 11.5% of the respondents are hired on a permanent contract, while there is a very high percentage (74.8%) of atypical contracts, with even some coordinators who say they have been working for several months as unpaid volunteers. It is interesting to note that over 30% of staff with atypical contracts work in research institutes and research-related scientific societies, with a strong interest in non-profit clinical research. Adopt Clinical Trials Units officially and contractually recognized would be essential to bring back our nation on the top of the world health systems ranking, but yet the Italian research-dedicated infrastructures continue to be a ghost reality, deeply characterized by a continuous professional turnover and by the lack of long-term prospects. In the absence of a permanent solution, Italy is unlikely to reach the required standards, denying patients of possible therapeutic available options. Our non-profit research will pay the most for it.

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. PATIENTS AND METHODS: We conducted a multicenter randomized trial of tamoxifen, 5 mg/d or placebo administered for 3 years after surgery in women with hormone-sensitive or unknown breast intraepithelial neoplasia, including atypical ductal hyperplasia and lobular or ductal carcinoma in situ. The primary end point was the incidence of invasive breast cancer or ductal carcinoma in situ. RESULTS: Five hundred women 75 years of age or younger were included. After a median follow-up of 5.1 years (interquartile range, 3.9-6.3 years), there were 14 neoplastic events with tamoxifen and 28 with placebo (11.6 v 23.9 per 1,000 person-years; hazard ratio, 0.48; 95% CI, 0.26 to 0.92; P = .02), which resulted in a 5-year number needed to treat of 22 (95% CI, 20 to 27). Tamoxifen decreased contralateral breast events by 75% (three v 12 events; hazard ratio, 0.25; 95% CI, 0.07 to 0.88; P = .02). Patient-reported outcomes were not different between arms except for a slight increase in frequency of daily hot flashes with tamoxifen (P = .02). There were 12 serious adverse events with tamoxifen and 16 with placebo, including one deep vein thrombosis and one stage I endometrial cancer with tamoxifen and one pulmonary embolism with placebo. CONCLUSION: Tamoxifen at 5 mg/d for 3 years can halve the recurrence of breast intraepithelial neoplasia with a limited toxicity, which provides a new treatment option in these disorders.

[Clinical research coordinators: a crucial resource.] / Coordinatori di ricerca clinica: una risorsa indispensabile.

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. Despite that, there is no yet an institutional recognition of the professional figure, neither a specific economical agreement within the National Health System. The lack of institutional recognition is causing a worrying phenomenon of migration of qualified 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.