Single-arm studies with external comparators for cancer drug development: a statistical methodology study to evaluate External Comparator Arm (ECA) study results versus Randomised Controlled Trial (RCT) results

14/10/2021
09/01/2025
EU PAS number:
EUPAS43709
Study
Finalised

ENCePP Code of conduct

No
Data sources

Data sources (types)

Other

Data sources (types), other

Data from RCTs and EMR data from patients from a network of community hospitals
Use of a Common Data Model (CDM)

CDM mapping

No
Data quality specifications

Check conformance

Unknown

Check completeness

Unknown

Check stability

Unknown

Check logical consistency

Unknown
Data characterisation

Data characterisation conducted

No