DARWIN EU® - Enhanced Preparedness of the DARWIN EU Network for regulatory questions in oncology – DARWIN OncoNet

10/11/2025
17/07/2026
EU PAS number:
EUPAS1000000824
Study
Ongoing
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Study summary
No information provided.
Study identification

EU PAS number

EUPAS1000000824

Study ID

1000000824

Official title and acronym

DARWIN EU® - Enhanced Preparedness of the DARWIN EU Network for regulatory questions in oncology – DARWIN OncoNet

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Italy
Netherlands
Norway
Spain
Sweden
United Kingdom

Study description

There is a regulatory need to perform real-world data (RWD) studies in oncology. However, several
DARWIN EU® studies were not feasible due to the absence of key variables, limited granularity of data, and
analytical pipelines required to address specific regulatory questions. Some of these data elements are
available in certain data sources (source data) within the DARWIN EU® Data Network but have not yet been
mapped to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM).
This study focuses on improving data quality (with specific focus on extensiveness and reliability) related to
oncology in the DARWIN EU® Data Network, as well as enhancing the analytical pipelines that will facilitate
future oncology studies in DARWIN EU®. This initiative is important for advancing the use of RWD in cancer
research by ensuring accurate, detailed data representation, and the availability of appropriate analytical
tools.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Talita Duarte-Salles

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
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