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

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

Finnish Institute for Health and Welfare (THL)

Finland

Pharmacoepidemiology and Drug Safety Research Group (PharmaSafe), University of Oslo

Norway

Drugs and Pregnancy, Finnish Institute for Health and Welfare (THL)

Finland

The Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO)

Spain

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

Networks

ConcepTION

Study timelines

Date when funding contract was signed

Actual: 01/04/2019

Study start date

Actual: 08/05/2021

Date of final study report

Planned: 31/12/2024

Sources of funding

EU institutional research programme

More details on funding

Innovative Medicines Initiative

Study protocol

Initial protocol

Breast Cancer Protocol_PABC_Final_093021

Regulatory

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