Life Sciences Horizons Brochure 2025 - Flipbook - Page 50
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2025 Horizons Life Sciences and Health Care
AIFA’s new guidelines on non-interventional clinical studies: A step toward
streamlined research and real-world data integration
In August 2024, the Italian Medicines Agency (AIFA)
released updated guidelines on non-interventional
(observational) clinical studies, aimed at clarifying key
regulatory aspects and simplifying processes.
The new guidelines are dedicated, like the previous ones, to
pharmacological, observational studies. However, AIFA took
care to specify in their preamble that these guidelines can be
taken “as a reference” also in the evaluation activities of nonpharmacological, observational studies, legitimizing a
consolidated practice in the absence of a codified procedure
for observational studies that do not involve medicines.
(e.g., CE marked medical devices).
For years, industry groups have called for clearer regulatory
guidance on designing study protocols and managing ethical
review processes. AIFA’s new guidelines address these concerns,
streamlining the approval process and providing clarity on
regulatory requirements. This simplification is expected to
reduce delays, enhance research efficiency, and increase Italy’s
competitiveness in global pharmaceutical research.
Non-interventional studies, which observe patient outcomes
without altering treatment regimens, are essential in assessing
drug efficacy and safety in real-world settings. With the increasing
availability of health data from electronic health records, wearable
devices (e.g., smartwatches), and other digital health tools, these
studies can now provide valuable insights into how treatments
perform outside clinical trial environments. AIFA’s guidelines
acknowledge this shift, highlighting the integration of
pharmacogenetics and pharmacogenomics, and the potential
for generating knowledge from compassionate use programs.
The guidelines also stress the importance of data protection and
patient consent, ensuring that observational studies comply
with GDPR and maintain transparency throughout the research
process. With the increased volume and complexity of health
data, AIFA emphasizes the need to integrate information from
diverse platforms while safeguarding privacy.
For pharmaceutical companies, adapting to these updated
guidelines is essential for navigating the changing regulatory
environment and taking advantage of new opportunities in
observational research.
Giuseppe Aminzade
Counsel
Milan
