Study identification

EU PAS number

EUPAS1000000791

Study ID

1000000791

Official title and acronym

Study protocol objective 2_feasibility assessement: Comparative effectiveness and safety studies using the target trial emulation and estimand frameworks (TARGET-EU-FA)

DARWIN EU® study

No

Study countries

Belgium
Denmark
Finland
Greece
Italy
Netherlands
Spain
United Kingdom

Study description

The overarching goal of the project "Comparative effectiveness and safety studies using the target trial emulation and estimand frameworks (TARGET-EU)", is 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

Teamit Institute
Spain
First published:
12/03/2024
Institution Other ENCePP partner
Sint Antonius Hospital; Ghent University; University of Copenhagen (UCPH).

Networks

Contact details

Mònica Sabaté 0000-0001-6206-1085

Primary lead investigator
ORCID number:
0000-0001-6206-1085

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable