An Expert Consensus-Based Review of Considerations for Developing a Quality Management System Framework for Studies...

Area of Science:

• Pharmacoepidemiology
• Health Data Science
• Regulatory Science

Background:

• High-quality pharmacoepidemiological research is vital for generating credible real-world evidence (RWE).
• Existing Quality Management Systems (QMS) are primarily designed for primary data collection (e.g., clinical trials).
• Adapting QMS for secondary data sources is necessary to meet regulatory expectations for RWE.

Purpose of the Study:

• To explore the adaptation of pharmaceutical QMS for RWE studies using secondary data.
• To identify fit-for-purpose considerations for proportional oversight, data integrity, and regulatory-grade evidence generation.
• To assess the applicability of existing QMS frameworks to secondary data utilization in RWE.

Main Methods:

• An international working group (WG) of RWE experts utilized the Nominal Group Technique.
• WG assessed applicability and adaptation needs of QMS elements for secondary data RWE.
• A targeted literature review examined regulatory guidance (EU, USA, UK) on quality systems for RWE.

Main Results:

• 12 out of 21 identified quality systems were most relevant for secondary data RWE studies.
• Ten of these relevant systems require contextual adaptations for RWE.
• Quality manuals and quality control were most frequently addressed in literature; vendor management was not explicit.

Conclusions:

• Existing QMS frameworks require fit-for-purpose adaptation for RWE studies utilizing secondary data.
• Adaptation is essential to support scientifically robust and regulatory-relevant RWE.
• This review provides a foundation for developing tailored QMS for secondary data RWE.