FREN
Case study

National interventional institutional study on the management of acute coronary syndromes in France

Background

A study of acute coronary syndromes, this programme was conducted under the auspices of a learned society in cardiology, in collaboration with numerous French hospitals.

With more than 5,291 patients enrolled, the programme aimed to assess real-world practices in the management of myocardial infarction, measure their short- and long-term clinical impact, and improve the overall understanding of acute coronary syndromes in the hospital setting.

This acute coronary syndrome study was based on the observation of management practices in various French hospitals. It provided data from real clinical situations and a better understanding of how the patients concerned are managed. The analysis of practices was an important element in identifying possible differences in care pathways and assessing how they evolve over time.

In this interventional clinical study, data collection and follow-up required structured organisation between the participating sites. The diversity of the hospitals involved made it possible to take different hospital settings into account and to document the practices observed in several regions. These data contributed to a better understanding of the management of acute coronary syndromes in France and of its clinical challenges.

The programme was therefore part of an approach aimed at producing data to improve practice and the understanding of care pathways in cardiology. It also made it possible to better document the practices observed at the participating hospitals and to contribute to a structured analysis of the data collected from patients.

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 main challenges of this national project were:

The scale of recruitment and the constraints of emergency care made rigorous organisation and accurate documentation of clinical information essential.

Pharmaspecific’s role

Pharmaspecific contributed to this study through the entry of CRF (Case Report Form) data.

Its teams ensured meticulous and compliant entry of the clinical information collected, thereby contributing to the quality and reliability of the national registry.

This assignment effectively supported the continuity and consistency of data follow-up from the participating sites. It also helped to consolidate the information collected and to maintain consistent data quality throughout the project, in line with the defined procedures. This organisation enabled structured processing of the clinical data and their use within the study.

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

Creation of a national reference registry on the management of myocardial infarction in France. • More than 80 international scientific publications between 2015 and 2024, reflecting the richness of the data collected.

Use of the registry to improve clinical and organisational practices in the management of acute coronary syndromes.

Key takeaways

This project illustrates the ability of Pharmaspecific to:

Through this assignment, Pharmaspecific confirms its know-how in the entry and operational management of clinical study data, in support of cardiovascular research.