Case study

National real-world clinical data (RWD) centralisation project in oncology

Background

The national real-world clinical data centralisation project established a platform to centralise and harmonise clinical information from several French hospitals, covering a range of major oncology indications.

The aim of this initiative was to build a robust database to support precision oncology research and enable large-scale epidemiological and medico-economic analyses.

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 presented several significant challenges:

ensuring the quality and consistency of data from multiple hospital sources,
standardising formats and variables to enable cross-cutting analyses,
strictly complying with the General Data Protection Regulation (GDPR), given the sensitive nature of the health data collected

Pharmaspecific’s role

Pharmaspecific took part in the entry and validation of clinical data, ensuring their completeness and compliance with the defined quality standards. As part of this project, its team helped to strengthen the reliability of real-world clinical data in oncology, enabling information to be made available quickly and in a usable form for academic and industry partners.

This approach is aligned with the principles governing the collection and use of health data, in accordance with the recommendations of the European Health Data Space (EHDS).

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

Key takeaways

This project illustrates Pharmaspecific's ability to contribute effectively to national real-world clinical data initiatives, combining methodological rigour, compliance with regulatory requirements and a thorough understanding of the challenges of oncology research. Through this experience, Pharmaspecific confirms its active involvement in the development of precision oncology and in making the most of clinical data to support research and innovation.

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