Factors Affecting Citizen Trust and Public Engagement Relating to the Generation and Use of Real-World Evidence in Healthcare

Denis Horgan¹, Bettina Borisch², Ivana Cattaneo³, Mark Caulfield⁴, Arturo Chiti^{5

6}, Christine Chomienne⁷, Amanda Cole⁸, Karen Facey⁹, Allan Hackshaw¹⁰, Minna Hendolin¹¹, Nadia Georges¹², Dipak Kalra¹³, Birutė Tumienė¹⁴, Martina von Meyenn¹⁵

Affiliations

¹ European Alliance for Personalised Medicine, 1040 Brussels, Belgium.
² Department of Histopathology, University of Geneva, 1202 Geneva, Switzerland.
³ Novartis Farma SpA, 21040 Origgio, Italy.
⁴ NIHR Barts Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London EC1M 6BQ, UK.
⁵ Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Pieve Emanuele, 20090 Milan, Italy.
⁶ IRCCS Humanitas Research Hospital, Via Manzoni 56, Rozzano, 20089 Milan, Italy.
⁷ Cell Biology-Hematology Department, Université de Paris INSERM, 75010 Paris, France.
⁸ Office of Health Economics, London SW1E 6QT, UK.
⁹ Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh EH8 9YL, UK.
¹⁰ Faculty of Medical Sciences, University College London, London W1T 4TJ, UK.
¹¹ Sitra-The Finnish Innovation Fund, 00180 Helsinki, Finland.
¹² Exact Sciences, 1201 Geneva, Switzerland.
¹³ Faculty of Medicine and Health Sciences, University of Ghent, 9000 Ghent, Belgium.
¹⁴ Vilnius University Hospital Santariskiu Klinikos, 08661 Vilnius, Lithuania.
¹⁵ F. Hoffmann-La Roche AG, 4070 Basel, Switzerland.

PMID: 35162696
PMCID: PMC8835047
DOI: 10.3390/ijerph19031674

Factors Affecting Citizen Trust and Public Engagement Relating to the Generation and Use of Real-World Evidence in Healthcare

Denis Horgan et al. Int J Environ Res Public Health. 2022.

. 2022 Feb 1;19(3):1674.

doi: 10.3390/ijerph19031674.

Authors

Affiliations

¹ European Alliance for Personalised Medicine, 1040 Brussels, Belgium.
² Department of Histopathology, University of Geneva, 1202 Geneva, Switzerland.
³ Novartis Farma SpA, 21040 Origgio, Italy.
⁴ NIHR Barts Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London EC1M 6BQ, UK.
⁵ Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Pieve Emanuele, 20090 Milan, Italy.
⁶ IRCCS Humanitas Research Hospital, Via Manzoni 56, Rozzano, 20089 Milan, Italy.
⁷ Cell Biology-Hematology Department, Université de Paris INSERM, 75010 Paris, France.
⁸ Office of Health Economics, London SW1E 6QT, UK.
⁹ Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh EH8 9YL, UK.
¹⁰ Faculty of Medical Sciences, University College London, London W1T 4TJ, UK.
¹¹ Sitra-The Finnish Innovation Fund, 00180 Helsinki, Finland.
¹² Exact Sciences, 1201 Geneva, Switzerland.
¹³ Faculty of Medicine and Health Sciences, University of Ghent, 9000 Ghent, Belgium.
¹⁴ Vilnius University Hospital Santariskiu Klinikos, 08661 Vilnius, Lithuania.
¹⁵ F. Hoffmann-La Roche AG, 4070 Basel, Switzerland.

PMID: 35162696
PMCID: PMC8835047
DOI: 10.3390/ijerph19031674

Abstract

The potential for the use of real-world data (RWD) to generate real-world evidence (RWE) that can inform clinical decision-making and health policy is increasingly recognized, albeit with hesitancy in some circles. If used appropriately, the rapidly expanding wealth of health data could improve healthcare research, delivery of care, and patient outcomes. However, this depends on two key factors: (1) building structures that increase the confidence and willingness of European Union (EU) citizens to permit the collection and use of their data, and (2) development of EU health policy to support and shape data collection infrastructures, methodologies, transmission, and use. The great potential for use of RWE in healthcare improvement merits careful exploration of the drivers of, and challenges preventing, efficient RWD curation. Literature-based research was performed to identify relevant themes and discussion topics for two sets of expert panels, organized by the European Alliance for Personalised Medicine. These expert panels discussed steps that would enable a gradual but steady growth in the quantity, quality, and beneficial deployment of RWE. Participants were selected to provide insight based on their professional medical, economic, patient, industry, or governmental experience. Here, we propose a framework that addresses public trust and access to data, cross-border governance, alignment of evidence frameworks, and demonstrable improvements in healthcare decisions. We also discuss key case studies that support these recommendations, in accordance with the discussions at the expert panels.

Keywords: citizen trust; evidence framework; real-world data; real-world evidence.

PubMed Disclaimer

Conflict of interest statement

All authors received research support in the form of third-party medical-writing assistance for this manuscript, provided by F. Hoffmann-La Roche Ltd. D.H. is an employee of the European Alliance for Personalised Medicine, which receives funding from both the public and private sectors. B.B. has received speaker honoraria from F. Hoffmann-La Roche Ltd. I.C. is an employee of and holds stocks in Novartis. M.C. has received travel expenses from Servier for a symposium at INSERM, Paris, France. A.Ch. has received speaker honoraria from Amgen, Blue Earth Diagnostics, and Novartis, and has participated in advisory boards for Blue Earth Diagnostics and Novartis. A.Co. is an employee of the Office of Health Economics, which receives funding from a variety of sources, including pharmaceutical companies. K.F. has received funding from the Canadian Agency for Drugs and Technologies in Health, the European Course for Pharmaceutical Medicine, FIPRA (a Belgian policy organization), the National Institute for Health and Disability (Belgian healthcare payer), and Novartis. A.H. has participated in advisory boards for AbbVie and GRAIL Inc, has received personal fees for delivering general education/training in clinical trials from AbbVie, AstraZeneca, Boehringer Ingelheim, Clovis Technology, Daiichi Sankyo, F. Hoffmann-La Roche Ltd, Merck Serono, Merck/MSD, Servier, Takeda, and UCB, and has received fees for participation in Independent Data Monitoring Committees for Roche-sponsored clinical trials. M.H. has received fees for a consultancy role from Roche Finland. N.G. is an employee of Exact Sciences. D.K. is an employee of the University of Ghent, which receives funding for pre-competitive research from multiple sources, including research grants from the European Innovative Medicines Initiative (part-funded by the European Association of Pharmaceutical Industry Associations) and event sponsorship from different companies including those in the pharmaceutical and health information and communications technology sectors. M.v.M. is an employee of and holds stocks in F. Hoffmann-La Roche Ltd. All other authors declare no additional conflict of interest.

Figures

**Figure 1**
Methodology used to assess the factors affecting citizen trust and public engagement relating to the generation and use of RWE in healthcare. EAPM, European Alliance for Personalised Medicine; HTA, health technology assessment; RWD, real-world data; RWE, real-world evidence.

See this image and copyright information in PMC

References

1. Hechenbleikner E.M., Samarov D.V., Lin E. Data explosion during COVID-19: A call for collaboration with the tech industry & data scrutiny. EClinicalMedicine. 2020;23:100377. - PMC - PubMed
1. Cave A., Kurz X., Arlett P. Real-world data for regulatory decision making: Challenges and possible solutions for Europe. Clin. Pharmacol. Ther. 2019;106:36–39. doi: 10.1002/cpt.1426. - DOI - PMC - PubMed
1. Booth C.M., Karim S., Mackillop W.J. Real-world data: Towards achieving the achievable in cancer care. Nat. Rev. Clin. Oncol. 2019;16:312–325. doi: 10.1038/s41571-019-0167-7. - DOI - PubMed
1. Deverka P.A., Douglas M.P., Phillips K.A. Use of real-world evidence in us payer coverage decision-making for next-generation sequencing-based tests: Challenges, opportunities, and potential solutions. Value Health. 2020;23:540–550. doi: 10.1016/j.jval.2020.02.001. - DOI - PMC - PubMed
1. Feinberg B.A., Gajra A., Zettler M.E., Phillips T.D., Phillips E.G., Jr., Kish J.K. Use of real-world evidence to support FDA approval of oncology drugs. Value Health. 2020;23:1358–1365. doi: 10.1016/j.jval.2020.06.006. - DOI - PubMed

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Factors Affecting Citizen Trust and Public Engagement Relating to the Generation and Use of Real-World Evidence in Healthcare

Affiliations

Factors Affecting Citizen Trust and Public Engagement Relating to the Generation and Use of Real-World Evidence in Healthcare

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding