Ethics Committees Selection in Italy under EU Regulation 536/2014: A Three-year Governance Analysis.

Area of Science:

• Clinical Trials Regulation (EU) No. 536/2014 (CTR)
• Pharmaceutical Policy
• Health Services Research

Background:

• The EU's Clinical Trials Regulation (CTR) reformed clinical trial governance in Italy, shifting from a decentralized to a centralized ethics opinion model.
• This regulatory change raises questions about how sponsors choose Ethics Committees (ECs) under the new framework.

Purpose of the Study:

• To analyze geographical trends in sponsor-selected Ethics Committees (ECs) for clinical trials in Italy from January 2022 to January 2025.
• To investigate associations between EC selection and trial characteristics like therapeutic area, phase, and patient population.

Main Methods:

• A retrospective, three-year nationwide analysis of clinical trial data.
• Utilized data from the Italian Medicines Agency (AIFA) and the Clinical Trials Information System (CTIS).
• Employed longitudinal, descriptive, and comparative evaluation methods.

Main Results:

• Out of 1,462 identified clinical trials, 77.8% involved sponsor-proposed ECs.
• A significant geographical imbalance was observed, with 60.2% of proposals directed to Northern Italy, 26.4% to Central Italy, and 13.4% to Southern Italy and Islands.
• Non-commercial sponsors predominantly chose Territorial Ethics Committees (TECs) within their own region (64.7%), often within the same institution.

Conclusions:

• Sponsor-proposed ECs in Italy are concentrated in the North, with notable intra-regional clustering.
• Non-commercial sponsors exhibit a preference for regional TECs, aligning with their institutional location.
• Recent data show a slight increase in proposals to Central TECs, suggesting evolving patterns that warrant continued monitoring.