From Data to Decisions: Enhancing Real-World Data Quality: A Survey of Health Data Producers in France
Author(s)
Aurélie Lampuré, MPH, PhD1, Valérie MACHURON, PhD2, Sarah Alami, PhD3, Cécile Collignon, PhD4, Magali Lemaitre, PhD5, Henri Souchay, PhD6, Amparo Sanjuan, PhD7, Armelle Graciet, PhD8, Lionel Bensimon, MSc1, Mélody Monthéard, PhD9, CECILE BLEIN, PhD10, Laura Luciani, PhD11, Lucie de Léotoing, PhD12.
1MSD, Puteaux, France, 2ROCHE S.A.S., Boulogne-Billancourt cedex, France, 3Air Liquide Santé International, BAGNEUX, France, 4Sanofi, Gentilly, France, 5Health Data Expertise, Génissieux, France, 6GE Healthcare, Paris, France, 7Biomerieux, Lyon, France, 8SNITEM, Courbevoie, France, 9LEEM, Paris, France, 10Argenx, Zwijnaarde, Belgium, 11Merck, Lyon, France, 12Market Access Strategy, W.L. Gore & Associates, Paris, France.
1MSD, Puteaux, France, 2ROCHE S.A.S., Boulogne-Billancourt cedex, France, 3Air Liquide Santé International, BAGNEUX, France, 4Sanofi, Gentilly, France, 5Health Data Expertise, Génissieux, France, 6GE Healthcare, Paris, France, 7Biomerieux, Lyon, France, 8SNITEM, Courbevoie, France, 9LEEM, Paris, France, 10Argenx, Zwijnaarde, Belgium, 11Merck, Lyon, France, 12Market Access Strategy, W.L. Gore & Associates, Paris, France.
OBJECTIVES: The quality of real-world data (RWD) is essential for its reliability and effective application in health research. Fragmentation and scarcity of secondary data across various registries, coupled with challenges in conducting feasibility studies, present significant barriers to robust research. This survey aims to identify best practices for ensuring RWD quality and the effective conduct of feasibility studies.
METHODS: A survey was conducted among health data producers in France, led by the CSF (Strategic Committee for Health Industry and Technologies). The survey included questions on various themes related to quality and feasibility, such as data availability, governance of structured databases, access procedures, confidentiality, types and timing of shared information, partner adaptations, data extraction and reporting frequency, quality control tools and methods, project evaluation, representativity assessments, and regulatory compliance.
RESULTS: More than twenty health data producers participated, including registries, cohorts, and hospital health data warehouses. Most producers share information about protocols, variable lists, and data dictionaries once a non-disclosure agreement is established; however, few make this information publicly available. Partners engagement varies, with some using a Contract Research Organization for private partners or adjusting budgets for academic collaborations. Approximately half of the cohorts and registries update public dataset information annually. Concerns regarding confidentiality are cites as the primary reason for limited public sharing. About half of respondents utilize standardized tools for data quality evaluation, and most express interest in using standardized tools such as “REQUEST,” proposed by French HTA. Nearly all data producers conduct feasibility studies and maintain transparency portals to inform patients about ongoing studies.
CONCLUSIONS: This survey highlights existing best practices for ensuring high-quality RWD. Ongoing initiatives aim to develop a quality label for secondary use of health data within the EU, standardizing practices. Disseminating these best practices is crucial for enhancing RWD quality, a prerequisite for gaining fair recognition by health authorities.
METHODS: A survey was conducted among health data producers in France, led by the CSF (Strategic Committee for Health Industry and Technologies). The survey included questions on various themes related to quality and feasibility, such as data availability, governance of structured databases, access procedures, confidentiality, types and timing of shared information, partner adaptations, data extraction and reporting frequency, quality control tools and methods, project evaluation, representativity assessments, and regulatory compliance.
RESULTS: More than twenty health data producers participated, including registries, cohorts, and hospital health data warehouses. Most producers share information about protocols, variable lists, and data dictionaries once a non-disclosure agreement is established; however, few make this information publicly available. Partners engagement varies, with some using a Contract Research Organization for private partners or adjusting budgets for academic collaborations. Approximately half of the cohorts and registries update public dataset information annually. Concerns regarding confidentiality are cites as the primary reason for limited public sharing. About half of respondents utilize standardized tools for data quality evaluation, and most express interest in using standardized tools such as “REQUEST,” proposed by French HTA. Nearly all data producers conduct feasibility studies and maintain transparency portals to inform patients about ongoing studies.
CONCLUSIONS: This survey highlights existing best practices for ensuring high-quality RWD. Ongoing initiatives aim to develop a quality label for secondary use of health data within the EU, standardizing practices. Disseminating these best practices is crucial for enhancing RWD quality, a prerequisite for gaining fair recognition by health authorities.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD87
Topic
Methodological & Statistical Research, Real World Data & Information Systems
Topic Subcategory
Data Protection, Integrity, & Quality Assurance, Reproducibility & Replicability
Disease
No Additional Disease & Conditions/Specialized Treatment Areas