The future of Italian phase I trials regulation: lessons from a nationwide survey.

ABSTRACT:

Background

Phase I trials are critical for drug development and require rigorous oversight. In Italy, AIFA Determination 809/2015 introduced mandatory standards and a self-certification model, nearly a decade ago. Its sustainability and impact now warrant reassessment.

Methods

A nationwide cross-sectional survey (March-April 2024) was conducted among professionals involved in phase I trials. A 19-item questionnaire explored institutional characteristics, certification processes, quality structures and perceptions of the Determination. Descriptive analyses were performed.

Results

Sixty-two professionals responded, mainly Data Managers/Clinical Research Coordinators and Quality Assurance officers. Most centers conducted both industry and non-profit studies. Certificatio

SUBMITTER: Cagnazzo C 

PROVIDER: S-EPMC12647064 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature