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An Expert Consensus-Based Review of Considerations for Developing a Quality Management System Framework for Studies Utilising Secondary Data for Real-World Evidence Generation.

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Τίτλος: An Expert Consensus-Based Review of Considerations for Developing a Quality Management System Framework for Studies Utilising Secondary Data for Real-World Evidence Generation.
Συγγραφείς: Layton D; PEPI Consultancy Limited, 3 Neilson Close, Eastleigh, Southampton, Hampshire, UK. drdeborahlayton@outlook.com.; PHARMO Institute, Part of Lumanity, London, UK. drdeborahlayton@outlook.com.; School of Life Sciences, University of Hertfordshire, Hatfield, Hertfordshire, UK. drdeborahlayton@outlook.com., Porta A; Shella Consulting Limited, Hook, Hampshire, UK., Patel D; IQVIA Limited, Real-World Solutions, London, UK., Ramcharran D; GSK, Providence, RI, USA., Moride Y; Rutgers Center for Pharmacoepidemiology and Treatment Science, New Brunswick, NJ, USA.; YolaRx Consultants, Montreal, QC, Canada., Splendiani A; IQVIA AG, Basel, Switzerland., Kou TD; Clinical Safety and Pharmacovigilance, Daiichi Sankyo, Basking Ridge, NJ, USA., Eworuke E; IQVIA Limited, Real-World Solutions, London, UK., Riera-Arnau J; Department of Data Science and Biostatistics, University Medical Center Utrecht, Utrecht, The Netherlands.; Clinical Pharmacology Service, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain., Sreedharan S; IQVIA Limited, Real-World Solutions, Bengaluru, India., Oliveria SA; Thermo Fisher Scientific, PPD Observational Studies, Scientific Affairs, New York, NY, USA.
Πηγή: Pharmaceutical medicine [Pharmaceut Med] 2026 Jul; Vol. 40 (4), pp. 249-263. Date of Electronic Publication: 2026 Jun 06.
Τύπος έκδοσης: Journal Article; Review
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 101471195 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1179-1993 (Electronic) Linking ISSN: 11782595 NLM ISO Abbreviation: Pharmaceut Med Subsets: MEDLINE
Imprint Name(s): Publication: Auckland : Adis, Springer International
Original Publication: Auckland, N.Z. : Wolters Kluwer Health/Adis, 2008-
Ιατρικοί όροι (MeSH): Pharmacoepidemiology*/methods , Pharmacoepidemiology*/standards , Consensus Statements as Topic*, Data Collection/methods ; Humans ; Consensus ; Quality Control
Περίληψη: High-quality pharmacoepidemiological research is essential for credible real-world evidence (RWE). This expert consensus-based review explores how pharmaceutical Quality Management Systems (QMS) developed for studies using primary data collection (e.g., clinical trials, registries) can be adapted to support studies utilising secondary data to generate RWE, in line with regulatory expectations. The aim was to identify fit-for-purpose considerations for proportional oversight, data integrity, and regulatory-grade evidence generation. An international working group (WG) comprising RWE experts from industry, academia, and independent consultancy (including QMS specialist) assessed which elements of QMS frameworks developed for primary data collection are applicable to RWE studies utilising secondary data sources and those elements where adaptation would be required. Using the Nominal Group Technique, the WG identified and prioritised relevant quality systems and adaptation needs. In parallel, a targeted literature review of guidance and reports from International Coalition of Medicines Regulatory Authorities (ICMRA) member sites (focusing on the EU, USA and UK) assessed guidance against prioritized quality systems. Of 21 quality systems identified, 12 were considered most relevant to RWE studies utilising secondary data, with ten requiring contextual adaptations. The literature review identified 26 publications referencing one or more of these systems; quality manuals (69.2% (n = 18)) and quality control (34.6% (n = 9)) were most frequently addressed, whilst other systems were inconsistently covered; vendor management was not explicitly addressed. Overall, this review highlights the need for fit-for-purpose adaptation of existing QMS frameworks to support regulatory-relevant, scientifically robust RWE generated from secondary use of existing data sources.
(© 2026. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)
Competing Interests: Declarations. Conflict of Interest: All authors have no funding sources for this work and no conflicting relationships that existed at any time during the conduct/development of the work. DL was employed by Lane Clark and Peacock (LCP) LLP UK, during the preparation of this manuscript after the project was completed. DL is currently employed by PHARMO, part of Lumanity, UK and is Director of PEPI Consultancy Limited and has received funds from AstraZeneca Ltd, Ariello SRO and Annexon Biosciences Inc. DP, EE, AS and SS are full-time employees of IQVIA Ltd. DR is an employee of GSK and has stock options. YM is president of YolaRx Consultants. TDK is an employee at Daiichi Sankyo, Inc and receives stock incentives. JRA is currently salaried employee at University Medical Center Utrecht, which receives institutional research funding from pharmaceutical companies and regulatory agencies, administered by University Medical Center Utrecht. All these studies follow the ENCePP code of conduct. SAO is an employee of Thermo Fisher Scientific. AP is Managing Director of Shella Consulting Ltd. Ethical Approval: Not applicable. Consent to Participate: Not applicable. Consent for Publication: Not applicable. Code Availability: Not applicable. Availability of Data and Material: Not applicable. Authors’ Contributions: DL and AP contributed to the conceptualisation of the project, methodology, project administration, focus group discussions, and manuscript preparation. DP contributed to the conceptualisation of project, methodology, literature review, focus group discussions and manuscript preparation. DR, YM, TDK and SAO contributed to the conceptualisation of the project, methodology, focus group discussions and manuscript preparation. AS contributed expertise and comments related to Data Quality Frameworks. JRA and EE contributed to the methodology, interpretation of data, and critical review of the manuscript and group discussions. SS contributed to the methodology approach, literature review and manuscript preparation. All authors reviewed and commented on the manuscript at all stages of development, and all agree to be accountable for this work.
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Entry Date(s): Date Created: 20260606 Date Completed: 20260704 Latest Revision: 20260709
Update Code: 20260709
DOI: 10.1007/s40290-026-00609-x
PMID: 42250058
Βάση Δεδομένων: MEDLINE
Περιγραφή
ISSN:1179-1993
DOI:10.1007/s40290-026-00609-x