Fitness-for-Use Assessment across Four Data Sources for Real-World Safety and Effectiveness Studies of CAR-T cell therapies

ENCePP Code of conduct

Yes

Data sources

• Data source(s):
  Système National des Données de Santé (French national health system main database)

  Cancer Analysis System
• Data source(s), other:
  1. US Flatiron Health Research Database; 2. Dispositif d’Enregistrement et Suivi des patients traités par CAR-T cells (DESCAR-T);
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Cancer registry

  Disease registry

  Drug registry

  Electronic healthcare records (EHR)

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Yes
• Check completeness:
  Yes
• Check stability:
  No
• Check logical consistency:
  Yes

Data characterisation

• Data characterisation conducted:
  Yes
• Data characterisation moment:
  after data extraction

  after creation of study variables
• Data characterisation details:
  Data characterisation involved assessing whether NCRAS & HES, US Flatiron Health Research Database, SNDS and DESCAR T contained the necessary variables to support the three theoretical CAR T study scenarios. Following data extraction, key fields such as exposures, outcomes, covariates and dates were examined for completeness, precision and availability. Logical consistency checks were performed to identify implausible or duplicate records and verify alignment between related data elements. Additional checks were conducted after constructing study specific variables to confirm the feasibility of implementing inclusion and exclusion criteria for each scenario. The process focused on evaluating data suitability rather than generating any clinical outcomes or estimates.; ;

Data characterisation details

20250805_FWC_EMA_2020_46_TDA_L5.07_SC01 protocol objective 3_v1.0.pdf

Procedures

Procedure of data extraction

20250805_FWC_EMA_2020_46_TDA_L5.07_SC01 protocol objective 3_v1.0.pdf

Procedure of results generation

20250805_FWC_EMA_2020_46_TDA_L5.07_SC01 protocol objective 3_v1.0.pdf