The Italian Medicines Agency (AIFA) has published a comprehensive update to the guidelines for the classification and conduct of observational studies.
Observational studies play a crucial role in monitoring drug safety profiles in normal clinical use and across large populations. They also allow for an in-depth understanding of drug efficacy and usage in real-world settings, the appropriateness of prescriptions, and economic assessments. The new guidelines update and replace those from 2008, which had become outdated due to rapid advancements in the field.
Here are some of the key points included in the new guideline:
- Clear Study Classification: Differentiating observational studies from interventional trials, ensuring the use of authorized drugs in routine practice.
- Role of Ethics Committees: Mandating Ethics Committees to approve and oversee all observational studies.
- Mandatory Study Registry: Reaffirming the use of the Observational Studies Registry (RSO) for all studies conducted in Italy, enhancing transparency.
- Detailed Protocol Requirements: Establishing strict guidelines for study design, including the need for ethical review of protocol modifications.
- Streamlined Adverse Event Reporting: Aligning ADR reporting with pharmacovigilance practices to avoid duplication.
- Inclusive Study Sites: Expanding acceptable study sites to include general practitioners and non-traditional data collection methods like online platforms.
- Transparency in Economic Aspects: Requiring transparent disclosure of researcher compensation and scrutinizing economic aspects to avoid conflicts of interest.
- Simplified Consent Procedures: Simplifying data privacy and informed consent requirements in compliance with current laws.
- Mandatory Results Publication: Requiring that all study outcomes, including negative results, be published within 12 months.
These guidelines, effective immediately following their publication in the Official Gazette, represent a significant step forward in aligning Italy’s regulatory framework with the latest European standards.
RPN will provide any further update and is available to provide full support for Clinical Studies activities.