Analysis of pregnancy pharmacovigilance data in spontaneous reports, and literature, (Individual Case Safety Reports originating from published case series, non-interventional studies and patient support programmes); demonstration study 2.5.1 of the ConcePTION project

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39263
• EU PAS number:
  EUPAS38841
• Study ID:
  39263
• Official title and acronym:
  Analysis of pregnancy pharmacovigilance data in spontaneous reports, and literature, (Individual Case Safety Reports originating from published case series, non-interventional studies and patient support programmes); demonstration study 2.5.1 of the ConcePTION project
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Netherlands

  South Africa

  Switzerland

  United Kingdom
• Study description:
  Since limited data from studies performed pre-marketing are usually available before licensure of a medicinal product, we have to rely on post-marketing data from both primary as well as secondary data sources. The IMI funded ConcePTION project aims to enhance the way drug use during pregnancy is studied. This is in part achieved by improving the collection, analysis and interpretation of pharmacovigilance (PV) data, to allow for a more systematic analysis and exchange of data. Work Package 2 (WP2) focusses on sources of primary data collection, such as spontaneous reports, data collected by Teratogen Information Services (TIS), literature, pregnancy registries, and enhanced PV studies. Tools developed for the analysis of spontaneous reports, however, were not specifically aimed at the analysis of safety information related to pregnancy. As a first step, this demonstration study will aim to gain insight into the nature of information on drug exposure during pregnancy from spontaneous reports and literature reports as filed in the ICSR databases of national PV centres and Marketing Authorisation Holders. The category literature reports therefore encompass Individual Case Safety Reports originating from published case series, non-interventional studies and Patient Support Programmes. In order to achieve this general aim, 5 sub-studies have been designed. The first sub-study aims to describe the nature and content of spontaneous reports and literature data sources. The second sub-study aims to create and validate a dedicated assessment tool for measuring the clinical quality of pregnancy data specifically, and the third sub-study aims to use this newly developed tool in order to describe the quality of reports in spontaneous reports and literature. Sub-study 4 will assess predictors of currently used teratogen signal detection techniques in ICSR databases and sub-study 5 aims to explore cluster analysis as a possible new teratogen signal detection technique.
• Study status:
  Planned

Research institution and networks

Institutions

Netherlands Pharmacovigilance Centre Lareb

Netherlands

Netherlands Pharmacovigilance Centre Lareb

Netherlands

Novartis Pharmaceuticals

Novo Nordisk

Swiss Teratogen Information Service

KRISP University of KwaZulu-Natal Durban, South Africa, Novartis Pharma AG Basel, switzerland, Novo Nordisk Bagsvaerd, Denmark, Swiss Teratogen Information Service Lausanne, Switzerland, UK Teratology Information Service Newcastel United Kingdom

Networks

ConcepTION

Study timelines

Date when funding contract was signed

Planned: 06/09/2018

Study start date

Planned: 01/04/2021

Date of final study report

Planned: 01/04/2024

Sources of funding

EU institutional research programme

More details on funding

Innovative Medicines Initiatiive

Study protocol

Initial protocol

Protocol_ConcePTION_Demo2_5_1_V1.0

Regulatory

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