TARGET-EU: Feasibility assessment based on the Data Quality Framework for EU medicines regulation.

Study type

• Study type:
  Not applicable
• Scope of the study:
  Method development or testing

  Other

Study design details

• Main study objective:
  Objective 1: To develop an overview of advantages and challenges of combining target trial emulation with the estimand framework for comparative efficacy and safety studies ; ; Objective 2: To characterise which types of European RWD sources are suitable to be used in the context of TTE studies and key aspects that should be attended to in a feasibility assessment of data sources for running such a study ; ; Objective 3: To establish criteria for suitable regulatory cases, including PAES, PASS and clinical trials with external controls, that would benefit from TTE approach; ; Objective 4: To develop good practices to aid in communication of the TTE studies for regulatory purposes
• Setting:
  The ten case studies in the proposal are going to utilise data sources, included in the EU PE&PV Consortium Framework Contract EMA/2020/46/TDA/L5.06, from the Netherlands, Spain, UK, Greece, Denmark, Italy, Finland, Belgium, Latvia and Norway.