Identification, Characterisation, and Data Quality Assessment of Data Sources for Real-World Safety and Effectiveness Studies of Chimeric antigen receptor T-cell (CAR-T cell) therapies

Data sources

• Data source(s):
  Cancer Analysis System

  Danish registries (access/analysis)

  Norwegian Health Registers

  Système National des Données de Santé (French national health system main database)

  Therapy Monitor Multiple Myeloma Germany
• Data source(s), other:
  1. all4cure Multiple Myeloma Register; 2. CART-SIE Registry; 3. Center for International Blood and Marrow Transplant Research (CIBMTR) Registry; 4. Cell Therapy Consortium Registry; 5. Clinformatics Data Mart (OptumInsight); 6. ConcertAI EMR and Claims Datasets; 7. COTA Real World Evidence Database; 8. DESCAR-T (Dispositif d’Enregistrement et Suivi des patients traités par CAR-T cells); 9. Dutch CAR-T Tumorboard (“Follow that CAR!”); 10. EBMT CAR-T Cell Registry (European Society for Blood and Marrow Transplantation); 11. European Mantle Cell Registry; 12. German Registry for Stem Cell Transplantation (DRST); 13. GELTAMO/GETH-TC Registry; 14. IBM MarketScan Commercial and Medicare Databases; 15. iKnowMed (US Oncology Network); 16. IQVIA PharMetrics Plus Database; 17. Inovalon Closed Claims Database; 18. Lymphoma Innovations ORIEN Network (LION); 19. Memorial Sloan Kettering Cancer Center Database; 20. Medicare Fee-for-Service Database; 21. National Cancer Database (NCDB); 22. National Inpatient Sample (NIS); 23. Nationwide Readmissions Database (NRD); 24. Norstella EMR/EHR (Panalgo); 25. OncoHealth; 26. Pediatric Real World CAR Consortium (PRWCC) Database; 27. PINC AI Healthcare Database (formerly Premier Healthcare Database); 28. RealySA Cohort (REal world dAta in LYmphoma and Survival in Adults); 29. Sarah Cannon Transplant and Cellular Therapy Network (SCTCTN) CAR-T Registry; 30. SEER Program (Surveillance, Epidemiology, and End Results); 31. Sema4 (GeneDx) Electronic Health Records; 32. Swedish National Population-Based Registries; 33. Symphony Integrated Dataverse (IDV); 34. Touchstone (Definitive Healthcare); 35. TriNetX Research Network; 36. University of California Health Data Warehouse; 37. US Flatiron Health Research Database; 38. Vizient Clinical Data Base (CDB)
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Cancer registry

  Disease registry

  Drug registry

  Electronic healthcare records (EHR)

  Population registry

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Yes
• Check completeness:
  Yes
• Check stability:
  Yes
• Check logical consistency:
  Yes

Data characterisation

• Data characterisation conducted:
  Yes
• Data characterisation moment:
  after data extraction
• Data characterisation details:
  The foundational data quality and descriptive elements of 43 data sources were extracted based upon published information for each of the included data sources. This list of metrics was developed and adapted from the list of metadata for the HMA-EMA Catalogues of RWD sources and studies.

Data characterisation details

20250718_FWC_EMA_2020_46_TDA_L5.07_SC01 protocol objective 2 v1.0.pdf