Methodology, biostatistics,
data-management
The Methodology and Biostatistics Unit (MBDU) has expertise in methodology, statistics and data management in different areas of clinical research and research on existing data “Real Word data”.
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The methodology includes writing protocols, choosing the design of a study, calculating the number of subjects to include and assistance in writing medical articles.
The MBDU creates and manages databases, including sending consistency checks to ensure the correct completion and accuracy of the data contained in the databases. This role is all the more important since the quality of the data directly impacts the results of a study. This unit also carries out analyses in clinical trials (efficacy, tolerance, predictive markers of drug efficacy or management techniques) and observational studies. It also writes the analysis reports that will be sent to the authorities to close the studies.
The team, led by Dr. Aurélie Bertaut, is composed of:
- 4 Biostatisticians, 1 data scientist
- 2 clinical research data managers and 1 data research data manager,
- 1 TEC,
- 1 regulatory project manager, 1 data protection officer
- of interns and interns welcomed regularly.
All of them work in close collaboration with the clinical research teams and doctors at the establishment.
The research
The team is involved in the methodology of research projects, that is, the design and writing of protocols, the choice of study design, the calculation of the number of subjects to be included and the writing of medical articles.
The MBDU also manages databases, creating databases for data entry from research projects and ensuring consistency between these data. This role, carried out in conjunction with the promotion team, is crucial because data quality directly impacts the results of a study. Statisticians manage the analyses of studies and clinical trials with a view to promoting the results, through publications in scientific journals or at conferences (oral presentations and posters).
National level participations
The multidisciplinarity and versatility of the team allow it to participate in projects of national scope, such as the CANTO projects, a cohort of more than 12,000 women affected by localized breast cancer, ODH, a French platform on the use of anti-cancer therapies in real life, but also the ESME programs.
These projects are led by UNICANCER. The team is the reference statistical platform for the CANTO and ODH projects and is involved in the analysis of real-life data from ESME lung and ovary.
The team participates in the CONSORE and ONCODS projects led by UNICANCER. Locally, it is responsible for setting up a health data warehouse, EDS, at the CGFL.
Today, thousands of data points are generated every day in hospitals, particularly in computerized patient records. Real-life data offers a unique opportunity to explore the tolerance and effectiveness of treatments on patients in “real life.” This data complements clinical trials in which patients are selected in limited numbers. Big Data now makes it possible to exploit this data on a very large scale and to cross-reference it.
The ConSoRe tool then allows, like a super-powerful search engine, to find information scattered throughout all the patient files of the cancer treatment centers participating in the project.
OncoDS is a federated health data warehouse project led by Unicancer, which involves 12 cancer treatment centers, including the CGFL. It was announced as the winner of the first wave of the France 2030 call for projects “Support and assistance for the creation of hospital health data warehouses.” The project aims to design a unique infrastructure dedicated to data sharing based on the networking of 12 local repositories of cancer treatment centers. This project should facilitate researchers’ access to high-quality multicenter data.
Locally, the EDS poses the challenge of data interoperability with that of other establishments. This EDS represents immense potential for cancer research.
Patient data is of course used with the utmost respect for their rights, including their right to information about how their data is used. The DPO is responsible for ensuring this respect.