Patient Experience Data in Non‑Interventional Studies Supporting EMA Marketing Authorisation Applications between 2018 and 2023

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001011
• Study ID:
  1000001011
• Official title and acronym:
  Patient Experience Data in Non‑Interventional Studies Supporting EMA Marketing Authorisation Applications between 2018 and 2023
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  This was a retrospective analysis of European Medicines Agency (EMA) regulatory documents to characterise the use of Patient Experience Data (PED) in Non‑Interventional Studies (NIS) included in initial marketing authorisation applications (MAAs) and extensions of indication (EoIs) submitted between 2018 and 2023
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pharmacoepidemiology and Pharmacovigilance Unit, Department of Pharmacy, Pharmacology and Health Technologies, Faculty of Pharmacy University of Lisbon (FFUL)

Portugal

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned:01/02/2025

Actual:15/03/2025

Study start date

Planned:15/03/2025

Actual:15/03/2025

Data analysis start date

Planned:01/06/2025

Actual:01/06/2025

Date of final study report

Planned:01/05/2026

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable