Romin Pajouheshnia

Aug 15, 2024 | onlinelibrary.wiley.com | Rosa Gini |Romin Pajouheshnia |Morris A. Swertz |Lia Gutierrez

1 Introduction In November 2020, the MINERVA (Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies) project (EUPAS39322) was initiated in response to the Heads of Medicines Agencies–European Medicines Agency (HMA–EMA) joint Big Data Task Force recommendation on “the identification of metadata” for regulatory decision-making on the choice of data source [1-3].

May 9, 2024 | onlinelibrary.wiley.com | Rosa Gini |Romin Pajouheshnia |Helga Gardarsdottir |Dimitri Bennett

Key Points This is the first systematic exploration of approaches to describe diversity across data sources generating RWE, and the challenges and opportunities implied by such diversity. The review identified 91 documents offering recommendations and examples for characterizing diversity, or leveraging data diversity in pharmacoepidemiologic research. Our scoping review provides the basis for a framework to characterize data sources used to generate RWE.