The Pharmacovigilance Unit (UFPV) of the Clinical Research Division of Gustave Roussy performs real-time assessment of the safety of the investigational medicinal products used in nearly 90 clinical trials sponsored by Gustave Roussy or by other academic sponsors, in particular, from the Ile-de-France region (within the framework of GIRCI*). Constant attention is paid to monitoring the safety of investigational medicinal products with regard to potential side effects in patients. This is called pharmacovigilance for clinical trials.

Lab members

Direction:

• Director: Gianluca Severi (Inserm DR2)
• Co-directors: Alexis Elbaz (Inserm DR2) – Pascal Guenel (Inserm DR2)
• Operational manager: Pascale Gerbouin-Rérolle

Research Axis:

Publications

By October 2022, data from the E3N-E4N cohort have contributed to the publication of more than 250 scientific papers.

Here is a selection of 20 recent key papers published by the Exposome and Heredity team (post 2010):

Exposome, Inheritance, Cancer and Health

This group belongs to the UMR 1018/CESP - Centre de recherche en épidémiologie et en santé des populations

Lab members

• Aba Naila Myriam
  Epidemiologist
• Allodji Rodrigue
  Biostatistician
• Bejarano Quisoboni Daniel    
  Epidemiologist
• Belhout Amel    
  Clinical research associate
• Boumaraf Amel    
  Clinical research associate
• Chappat Juliette    
  Biostatistician
• Chounta Stefania    
  Epidemiologist
• De Vathaire Florent    
  Epidemiologist
• Demoor Charlotte    
  Epidemiologist
• Ducos Claire    
  Epidemiologist
• Fresneau Brice    
  Epidemiologist

Major publications

1. Role of radiotherapy and chemotherapy in the risk of leukemia after childhood cancer: An international pooled analysis. Allodji RS, Tucker MA, Hawkins MM, Le Deley MC, Veres C, Weathers R, Howell R, Winter D, Haddy N, Rubino C, Diallo I, Little MP, Morton LM, de Vathaire F. Int J Cancer. 2020 Oct 26. doi: 10.1002/ijc.33361. Online ahead of print. PMID: 33105035
    

Epidemiology of radiation

This team is part of UMR 1018/CESP - Centre for research in epidemiology and population health

The team focuses its work on the epidemiology of the effects of ionizing radiation on health, as well as all aspects of quality of life of  long term survivors from childhood cancers

Principal teaching roles

The Department participates in the training of medical and pharmacy students, the Masters degree in Public Health and doctoral and post-doctoral researchers in clinical and epidemiological research, biostatistics, health economics and data-management.

There are two university lecturers from the University of Paris-South in the department:  Marie-Cécile Le Deley and Isabelle Borget.

Biostatistics and Epidemiology Office - Publications

• Biostatistics and Epidemiology Office publications, 2023 (PDF document)

Biostatistics and Epidemiology Office 

The Biostatistics and Epidemiology Office is part of the Clinical Research Division and has been labelled an Center for Data Handling by the National Cancer Institute (INCa) since 2007.

The Biostatistics and Epidemiology Office comprises about 40 members (statisticians, MDs in public health, pharmacists-statisticians, public health intern, data-managers, health economists, etc.) and has the following main missions: