Study identification

PURI

https://redirect.ema.europa.eu/resource/43394

EU PAS number

EUPAS43393

Study ID

43394

Official title and acronym

Studying drug exposure when disease is measured through accurate identification of an incident case: application to breast cancer in pregnancy (ConcePTION breast cancer demo)

DARWIN EU® study

No

Study countries

Finland
Norway
Spain
United Kingdom

Study description

The objective is to evaluate which pharmaco-epidemiological methods are best suited to assess treatment modalities, including drug utilisation in pregnancy for malignant disease. The goal is to study drug exposure when disease is measured through accurate identification of an incident case. Therapies for pregnancy associated breast cancer (PABC) are used as motivating examples. We will particularly focus on improving methods for developing measurements of medication exposure in hospital settings / secondary and tertiary care. This drug utilisation study will describe patterns of medication use in PABC and in breast cancer in non-pregnant women (non-PABC). We will also assess whether time at breast cancer diagnosis and timing of medication use in pregnancy impacts maternal survival and pregnancy outcomes.

Study status

Ongoing
Research institutions and networks

Institutions

The Foundation for the Promotion of Health and Biomedical Research of Valencian Region, FISABIO Spain, University of Swansea Wales

Networks

ConcepTION
First published:
01/02/2024
Network

Contact details

Maarit Leinonen

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Sources of funding
EU institutional research programme

More details on funding

Innovative Medicines Initiative
Study protocol
Initial protocol
English (935.55 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable