Statistical methods for time-to-event endpoints with non-proportional hazards in clinical trials pivotal for benefit risk decision making

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Other
• Data sources (types), other:
  Literature Review: MEDLINE, EMBASE. Review of EMA EPARS: paediatricdata.eu. Review of EMA Scientific Advice letters: AGES internal database. Simulation Study

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