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

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000791
• Study ID:
  1000000791
• Official title and acronym:
  TARGET-EU: Feasibility assessment based on the Data Quality Framework for EU medicines regulation.
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Denmark

  Finland

  Greece

  Italy

  Netherlands

  Spain

  United Kingdom
• Study description:
  This feasibility assessment is part of the broader project "Comparative effectiveness and safety studies using the target trial emulation and estimand frameworks (TARGET-EU)" (EUPAS1000000539), which aims to enhance the understanding of opportunities, limitations and challenges associated with using the target trial emulation (TTE) and estimand frameworks (EF) to design and conduct non-interventional studies (NIS) that support regulatory decision-making, using European real-world data (RWD) sources. Ten NIS with causal objectives to address comparative safety or effectiveness will be considered to develop this understanding. As the suitability and timeliness of the data sources used for conducting each of those studies are essential, a feasibility assessment will be performed. This protocol outlines a series of steps to assess the feasibility of conducting the studies within the TTE framework using the envisioned data sources.
• Study status:
  Finalised

Research institutions and networks

Institutions

Electronic Health Records (EHR) Research Group, London School of Hygiene & Tropical Medicine (LSHTM)

United Kingdom

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Health Services Research and Pharmacoepidemiology Unit (HSRP Unit) FISABIO

Spain

Real-World Evidence Team, University of Eastern Finland (RWE team)

Finland

Clinical Pharmacology, Vall d'Hebron Institut de Recerca (VHIR)

Spain

University Medical Center Utrecht (UMCU)

Netherlands

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

Pharmacology Unit - Veneto Pharmacovigilance Centre (Pharmacol UNIVR), University Hospital Verona

Italy

Department of Medicine/Laboratory of Hygiene and Environmental Protection, Democritus University of Thrace

Greece

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Clinical Data Science (IKNL), Netherlands Comprehensive Cancer Organisation

Netherlands

Agenzia regionale di sanità della Toscana (ARS Toscana)

Italy

Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency for Medicines and Medical Devices, AEMPS)

Spain

Teamit Institute

Spain

Sint Antonius Hospital; Ghent University; University of Copenhagen (UCPH).

Networks

Vaccine monitoring Collaboration for Europe (VAC4EU)

Belgium

Denmark

Finland

France

Germany

Italy

Netherlands

Norway

Spain

United Kingdom

EU Pharmacoepidemiology and Pharmacovigilance (PE&PV) Research Network

Netherlands

Pedianet network (So.Se.Te)

Italy

Study timelines

Date when funding contract was signed

Planned:19/09/2024

Study start date

Planned:10/10/2024

Actual:10/10/2024

Date of final study report

Planned:12/05/2025

Actual:12/05/2025

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable