Building a pregnancy pharmacovigilance model for the future: Can pregnancy data collected by ConcePTION partners be analysed using common standards developed by the ConcePTION project?

Study identification

• EU PAS number:
  EUPAS43370
• Study ID:
  43371
• Official title and acronym:
  Building a pregnancy pharmacovigilance model for the future: Can pregnancy data collected by ConcePTION partners be analysed using common standards developed by the ConcePTION project?
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  France

  Germany

  Israel

  Netherlands

  South Africa

  Switzerland

  United Kingdom
• Study description:
  The objective of this pilot study is to determine whether pregnancy data collected by ConcePTION partners can be analysed using common data standards, common clinical and technical definitions, and common reporting algorithms developed by the ConcePTION project. This study will test the degree to which data from various data access providers (DAPs) can conform to the definitions of the Core Data Elements (CDEs) established in ConcePTION. In particular, it will be evaluated whether conversion of the data structures of individual DAPs is possible in terms of clinical perspectives and technical processing perspectives. The feasibility of populating predefined table shells with existing pregnancy data from various data access providers will be tested. Prospective and retrospective cases from exposures in pregnancy and the peri-LMP period to drugs used for the indication of multiple sclerosis from the primary data collections participating in the ConcePTION project will be used in this pilot study. Pregnancy exposure reports in scope for this study will be obtained from three types of data collection methods: pregnancy registries (Gilenya (Novartis), Aubagio (Sanofi), the Dutch Pregnancy Drug Register), EFPIA enhanced pharmacovigilance (PRIM) programmes (Gilenya, Siponimod and ofatumumab (Novartis), worldwide pregnancy surveillance program of oral cladribine (MAPLE-MS) (Merck Healthcare KGaA)), and data from selected European Network of Teratology Information Services (ENTIS) databases. The ability of each DAP to create an analysis dataset of elements conforming to the definitions of the CDEs established in ConcePTION task 2.3 of Work Package 2 will be described and discussed together with the processes used by them. Using this dataset each DAP will be asked to populate pre-defined summary tables according to the guidance in the Statistical Analysis Plan.
• Study status:
  Planned

Research institutions and networks

Institutions

Swiss Teratogen Information Service

Novo Nordisk

Sanofi

Netherlands Pharmacovigilance Centre Lareb

Netherlands

Shamir Medical Center

Israel

Merck Sharp & Dohme LLC

United States

Novartis Pharmaceuticals

The Israeli Teratology Information Service, Israel Ministry of Health Jerusalem, Israel, Clinical Pharmacology and Toxicology Unit, TIS Zerifin, Shamir Medical Center (Assaf Harofeh), Zerifin, Affiliated to Sackler School of Medicine, Tel-Aviv University Tel Aviv, Israel, KRISP, University of KwaZulu-Natal Durban, South Africa, Merck Healthcare KGaA Darmstadt, Germany, Novartis Pharma AG Basel, Switzerland, Novo Nordisk Novo Alle DK-2880 Bagsvaerd, Denmark, Sanofi Paris, France, 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:30/09/2021

Date of final study report

Planned:30/09/2024

Sources of funding

EU institutional research programme

More details on funding

Innovative Medicines Initiative

Regulatory

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