Strengthening Use of Real-World Data in Medicines Development: Metadata for Data Discoverability and Study Replicability (MINERVA)

Study type

• Study topic:
  Other
• Study topic, other:
  Infrastructure and guidance development
• Study type:
  Not applicable
• If ‘Not applicable’, further details on the study type:
  EMA Big Data Initiative, Infrastructure and guidance development
• If ‘other’, further details on the scope of the study:
  Definition and description of metadata, visualisation catalogue proof of concept tool and development of a good practice guide

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)

Study design details

• Main study objective:
  To define the set of metadata that should be collected from RW data sources and to collect the metadata for at least 10 data sources for the future development & population of a public catalogue with searchability, dashboards, visualisation capabilities, and integration of different levels of access
• Data analysis plan:
  Not applicable

Documents

Study results

MINERVA_GoodPracticeGuide_10Jan2022

Study report

MINERVA_D4_WorkshopReport_Final

MINERVA_DataSourceSelection_Final_26March2021

Study, other information

MINERVA Full-metadata-list 10Jan2022

MINERVA_D5_Report_v1.1_28June2021

MINERVA_D9_Metadata-catalogue-10Jan2022

MINERVA_DataSourceSelection_Final_26March2021.pdf

Study publications

Pajouheshnia R, Gini R, Hyde E, Swertz MA, Sturkenboom M, Margulis AV, Franzoni…

Gini R, Pajouheshnia R, Hall GC, Platt RW, Setoguchi S, Perez-Gutthann S, Willa…