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Evaluation

Workshop/Symposium

Session: Symposia & Workshops: Session 1

Evaluation of data quality in multi-database pharmacoepidemiologic studies: current practices and future trends

Monday, August 26, 2024
10:30 AM – 12:00 PM CEST
Location: Auditorium
Background: With increasing use of real-world data (RWD) in drug utilisation, safety and effectiveness research, data quality remains a substantive limitation of conducting non-interventional studies. This is of particular concern in multi-database studies linking diverse data across several data sources, where apart from potential inaccuracies during extraction, transformation, and analysis steps, the fit-for purpose evaluation of a diverse data introduces complexities.

Objectives: To provide an overview of the current state of data quality assessment and best practices from several research networks in Europe, North America and Asia, by bringing examples from ConcePTION, VAC4EU, EU PE&PV Network, SIGMA, HCSRN, FDA Sentinel, PCORnet, TriNetX, and AsPEN. This symposium is based on a currently ongoing ISPE-funded manuscript on “Guidance and best practices for data quality checking and benchmarking of results in large multi-database pharmacoepidemiologic studies using heterogenous data sources” (Abtahi et al. 2023). All ISPE members, including researchers working on multi-database pharmacoepidemiologic studies and those involved in regulatory review and policy making, as well as students and early-career researchers can benefit from attending this symposium.

Description: The first talk by Dr Rosa Gini will discuss diversity across data sources and implications for data quality, with lessons learned from the DIVERSE initiative (the predecessor of this initiative). In the second talk, Prof Miriam Sturkenboom together with Ms Vjola Hoxhaj will present the INSIGHT data quality assessment tool and fit-for-purpose assessment from the ConcePTION, VAC4EU, EU PE&PV, and SIGMA Networks in Europe. Then, Dr Daniel Morales and Dr Donna Rivera can present a regulatory science perspective by introducing the EMA’s Data Quality Framework, and FDA’s Oncology Quality, Characterization and Assessment of Real-World Data (QCARD) Initiative, respectively. Moreover, the current state of data quality assessment in research networks of Asia will be presented by Dr Kenneth Man, using the example of AsPEN. And finally, Dr Jeffrey Brown will present lessons, opportunities, and challenges of data quality assessment in US and global research networks, such as HCSRN, FDA Sentinel, PCORnet and TriNetX. The talks are intended to provide a 60min didactic, with 30min reserved for an interactive Q/A session and an engaging discussion with the audience.