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

Area of Science:

• Clinical Research
• Health Policy
• Human Resources in Healthcare

Background:

• Clinical research complexity necessitates experienced, multidisciplinary staff.
• National health contracts in Italy often fail to recognize new professional roles.
• This creates instability and a potential professional gap, particularly impacting non-profit clinical research.

Purpose of the Study:

• To assess the prevalence of employment instability among Italian clinical research coordinators.
• To determine the extent to which Italian institutes have integrated this role with stable, permanent contracts.
• To evaluate changes in the employment situation over a two-year period.

Main Methods:

• A survey was conducted in November 2016 to map contractual issues for clinical research coordinators.
• A follow-up survey was repeated two years later to assess changes.
• Data analyzed the types of employment contracts (permanent vs. atypical) and their implications.

Main Results:

• In 2016, only 13.8% of coordinators had permanent contracts; 73.2% had atypical ones.
• By 2018, the situation worsened: 11.5% permanent, 74.8% atypical, with some unpaid volunteers.
• 67.5% of respondents anticipated negative impacts from government restrictions on atypical contracts.

Conclusions:

• The lack of permanent contracts for clinical research coordinators in Italy is a persistent and worsening issue.
• This instability hinders the development of recognized Clinical Trials Units and impacts Italy's global health system ranking.
• Addressing these contractual issues is crucial for advancing non-profit research and ensuring patient access to treatments.