Case study

Post-authorisation safety study of an antiviral for hepatitis C

Background

A post-authorisation safety study (PASS) was set up to assess the tolerability and safety of use of a new antiviral intended for patients with hepatitis C.

The main objective was to monitor the occurrence of adverse events under real-world conditions of use, in a population often receiving multiple medications and presenting associated comorbidities.

essai clinique international en maladie rare projet national de centralisation de données clinique en vie réelle, étude clinique de bioéquivalence, Étude clinique sur le diabète étude clinique sur la sécurité d'un agent de contraste

étude observationnelle multicentrique en oncologie

Challenges identified

The project involved several major challenges:

ensuring rigorous safety monitoring in a real-world clinical practice setting,
guaranteeing complete and accurate collection of adverse events,
and maintaining regulatory compliance with the European requirements governing PASS studies.

These constraints required close coordination between the investigator sites, the sponsor and the pharmacovigilance teams.

Pharmaspecific’s role

Pharmaspecific provided monitoring dedicated to safety surveillance (PV) for this post-authorisation safety study, ensuring the traceability and completeness of adverse event reports.

The team also contributed to site training and follow-up to ensure consistent reporting procedures and high-quality reporting, in line with the European requirements applicable to post-authorisation safety studies (PASS).

étude observationnelle multicentrique en oncologie essai clinique de phase III en myélome multiple ; étude de syndromes coronaires aigus

Results

étude observationnelle multicentrique en oncologie essai clinique de phase II en oncologie thoracique étude clinique de sécurité post-autorisation essai clinique international de phase III en lymphome

Adverse event reporting timelines in line with regulatory standards.

High completeness of adverse event (AE) forms.

Smooth communication between sites and the sponsor, facilitating the validation and analysis of safety data.

Key takeaways

This project illustrates Pharmaspecific's ability to ensure rigorous post-marketing surveillance in complex real-world settings, guaranteeing high-quality pharmacovigilance follow-up and compliance with the European requirements for PASS studies.

Medical Services