Capability and accuracy of usual statistical analyses in a real-world setting using a federated approach.

Methods: The objective of this project was to determine the capability of a federated analysis approach using DataSHIELD to maintain the level of results of a classical centralized analysis in a real-world setting. This research was carried out on an anonymous synthetic longitudinal real-world oncology cohort randomly splitted in three local databases, mimicking three healthcare organizations, stored in a federated data platform integrating DataSHIELD. No individual data transfer, statistics were calculated simultaneously but in parallel within each healthcare organization and only summary statistics (aggregates) were provided back to the federated data analyst.

Personalized Reimbursement Model (PRM) program: A real-world data platform of cancer drugs use to improve and personalize drug pricing and reimbursement in France.

Objective: This article describes the Personalized Reimbursement Model (PRM) program methodology, limitations, achievement and perspectives in using real-world data of cancer drugs use to improve and personalize drug pricing and reimbursement in France.

Materials And Methods: PRM platform aggregates Electronic Pharmacy Records (EPR) data from French medical centers (PRM centers) to build retrospective cohorts of patients treated with injectable cancer drugs in a hospital setting. Data extracted on January 1st, 2020, from breast cancer (BC) patients who received trastuzumab, trastuzumab emtansin or pertuzumab since January 1st, 2011, and from lung cancer (LC) patients who received bevacizumab or atezolizumab since January 1st, 2015, enabled recovering their injectable cancer drugs history from diagnosis date until December 30th, 2019, and served as dataset for assessment.

Pilot non dialysis chronic renal insufficiency study (P-ND-CRIS): a pilot study of an open prospective hospital-based French cohort.

Background: Before establishing a prospective cohort, an initial pilot study is recommended. However, there are no precise guidelines on this subject. This paper reports the findings of a French regional pilot study carried out in three nephrology departments, before realizing a major prospective Non Dialysis Chronic Renal Insufficiency study (ND-CRIS).

The Non-Dialysis Chronic Renal Insufficiency study (ND-CRIS): an open prospective hospital-based cohort study in France.

Background: Chronic kidney disease (CKD) amounts to a heavy burden for health services. There is no long-running epidemiological tool for CKD before dialysis. We here present the protocol for a cohort of patients with "non-dialysis" CKD receiving care in the Bourgogne-Franche-Comté region of France.