A data manager for a European organisation of doctors

By paying the salary of a data manager for 3 years, we enabled the EPSSG (the European association of paediatric oncologists specialised in soft tissue sarcoma) to analyse data from a completed clinical trial on rhabdomyosarcoma from new angles.

The goal was to analyse the combination of factors currently used to define the risk group stratification system and to determine whether another classification method should be used to improve patient treatments on the basis of their risk group. This study also advocates an international standardisation of the classification method.

A total of 2,138 patients were included in the study. This project demonstrated that replacing one of the factors resulted in a stratification that better identified patients at higher risk of relapse and made it possible to build a new stratification model. Specifically, in the new treatment protocol, a first category of children was transferred from the “high risk” to the “standard” risk group, which justifies the use of lighter treatments in the hope of reducing the long-term side effects caused by the treatments. On the other hand, a second category of patients was transferred to a higher risk group and will receive a heavier treatment in the hope of improving their survival chances. This new stratification will be further validated in the currently ongoing study on rhabdomyosarcoma.

This project also led to the signature of an international Memorandum of Understanding between Europe and the USA with the aim to merge their existing databases and define harmonised guidelines for the registration of new patients consistently to improve our understanding of the disease.