TARGET EU: Comparative effectiveness and safety studies using the target trial emulation and estimand frameworks

10/04/2025
22/05/2026
EU PAS number:
EUPAS1000000539
Study
Planned
Subscribe
Download as PDF
Study summary
No information provided.
Study identification

EU PAS number

EUPAS1000000539

Study ID

1000000539

Official title and acronym

TARGET EU: Comparative effectiveness and safety studies using the target trial emulation and estimand frameworks

DARWIN EU® study

No

Study countries

Belgium
Denmark
Finland
Italy
Netherlands
Spain
United Kingdom

Study description

This project, entitled Comparative Effectiveness and Safety Studies Using the Target Trial Emulation and Estimand Frameworks (TARGET EU), aims to advance regulatory use of real-world data (RWD) through application of target trial emulation (TTE) and estimand methodologies.

The overarching goal is to generate evidence that bridges randomized controlled trials (RCTs) and observational studies, supporting regulatory decisions where RCTs are infeasible.

TARGET EU comprises four objectives:
(1) to review and assess the integration of TTE with the estimand framework for evaluating drug effectiveness and safety,
(2) to characterise the suitability of diverse European RWD sources for TTE,
(3) to identify regulatory scenarios—such as PASS, PAES, and trials with external comparators—where TTE provides value, and
(4) to establish good practice guidelines for communicating TTE results to regulators.

To achieve these aims, we developed target trial protocols, emulation protocols, and conducted feasibility assessments and analyses across ten distinct case studies.

CS 1 (covid19) (EUPAS1000000995)
CS 2 (lung cancer) (EUPAS1000000987)
CS 3 (dapagliflozin) (EUPAS1000000979)
CS 4 (rivaroxaban) (EUPAS1000001001)
CS 5 (asthma) (EUPAS1000000989)
CS 6 (valsartan) (EUPAS1000001002)
CS 7 (valproate) (EUPAS1000000999)
CS 8 (rsv) (EUPAS1000000993)
CS 9 (tolvaptan) (EUPAS1000001005)
CS 10 (colon cancer) (EUPAS1000000996)

Additional information about each case study can be found in the resources tab within the protocol section.

The overall methodology for the feasibility assessment is described here: EUPAS1000000791.

Study status

Planned
Research institutions and networks

Institutions

Teamit Institute
Spain
First published:
12/03/2024
Institution Other ENCePP partner
Sint Antonius Hospital, SoSeTe-Pedianet, Ghent University

Networks

Contact details

Olaf Klungel

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Date of final study report

Planned:
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