(A-201) An evidence base to support the establishment of a fit-for-purpose quality management system for secondary data pharmacoepidemiological studies

Background: As real-world data takes a more prominent role in real-world evidence (RWE) generation, there is growing recognition that factors considered crucial to quality of primary and secondary data studies differ. While, Good Clinical Practices provide a quality governance framework for primary data collection studies, there is limited equivalent guidance for secondary data studies. This assessment is part of a broader initiative to provide recommendations on establishing a standardised quality management system (QMS) approach that is fit-for-purpose for the conduct of secondary data studies.

Objectives: To identify, review, and evaluate existing guidance on QMS to determine whether these are fit-for-purpose for secondary data studies. To describe and define which systems within a typical primary data pharmaceutical QMS are applicable to or require adaptation to RWE generated by secondary data.

Methods: A qualitative research approach was used involving an ISPE member focus group from various research settings and geographic regions. A targeted literature search appraised existing guidance, and a list of key quality systems based on primary data QMS was created. This served as a foundation for evaluating the applicability of these key quality systems to RWE/secondary data research. Via a consensus approach key barriers, limitations and recommended adaptations were identified and summarized.

Results: Three frameworks were used to provide conceptual guidance on QMS: ICH 6, ICH 8(R1), and ISO9001. Of 21 quality systems identified, 12 were deemed most relevant to RWE secondary data studies with 10 requiring substantial adaptation. These included: Quality Manual and/or Policy, Controlled Documents Management, Education and Training, Quality Issues Investigations – Corrective and Preventative Actions, Risk Management, Vendor Management, Quality Audits, Quality Metrics and Performance Management, Computer System Validation, and Quality Control. Two systems were considered adequate: Inspections Management and Pharmacovigilance QMS. Common considerations for systems requiring adaptation included lack of specificity for secondary data studies, guidance being embedded within the broader umbrella of non-interventional studies, and inapplicability to secondary data studies.

Conclusions: Our assessment demonstrates existing QMS guidelines are not adequate in their current state for the conduct of secondary data studies and a standardised QMS approach is needed. As RWE continues to evolve, many existing QMSs are likely to require tailored modifications, extensions, and/or new approaches to assure the quality of studies are fit for purpose when RWE is intended for regulatory submission