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

TL;DR

This study evaluates the impact of Italian phase I trial regulations and finds they impose significant operational burdens, suggesting a need for revision.

Contribution

The study provides insights into the operational challenges of AIFA Determination 809/2015 and suggests targeted revisions for sustainability.

Findings

Most centers found certification processes resource-intensive and timelines inconsistent.

Over half of inspected centers reported major deviations and voluntary suspensions of certification.

Respondents considered parts of the Determination outdated, especially regarding team composition and qualifications.

Abstract

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.

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.

Sixty-two professionals responded, mainly Data Managers/Clinical Research Coordinators and Quality Assurance officers. Most centers conducted both industry and non-profit studies. Certification of both clinical units and laboratories was common, but timelines varied widely and preparation was resource-intensive. Over half of inspected centers reported major or critical deviations and voluntary suspensions of certification were not infrequent. Clinical Trial Quality Teams were established in most centers, though key roles were often outsourced. Respondents identified procedure drafting and staff training as the most burdensome requirements and considered parts of the Determination outdated, particularly regarding team composition and personnel qualifications. Comparative references with other European frameworks (e.g., Spain and the United Kingdom) highlight differences in implementation models and timelines.

While AIFA Determination 809/2015 has strengthened safety and quality culture, it imposes significant operational burdens, especially on academic institutions. Targeted revision appears necessary to maintain high standards while improving sustainability and competitiveness of Italian phase I research.

Figures