TY - JOUR
T1 - Factors Affecting Citizen Trust and Public Engagement Relating to the Generation and Use of Real-World Evidence in Healthcare
AU - Horgan, Denis
AU - Borisch, Bettina
AU - Cattaneo, Ivana
AU - Caulfield, Mark
AU - Chiti, Arturo
AU - Chomienne, Christine
AU - Cole, Amanda
AU - Facey, Karen
AU - Hackshaw, Allan
AU - Hendolin, Minna
AU - Georges, Nadia
AU - Kalra, Dipak
AU - Tumienė, Birutė
AU - Von Meyenn, Martina
N1 - Funding Information:
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.
Funding Information:
Funding: This research was funded by Novartis, AstraZeneca, F. Hoffmann-La Roche Ltd., Exact Sciences, Eli Lilly, and Illumina.
Funding Information:
Across Europe, the European Commission aims to support the protection and improvement of citizen health and seeks to support healthcare systems through legislation, financial support, best-practice facilitation and sharing, and activities promoting health [20]. The current priorities for the European Commission include several initiatives: building a strong EHU, protecting citizen health, providing support for tackling future health crises, and improving healthcare system resilience [21]. As indicated above, the scope of the actions that might be taken under this initiative remain under question, due to divergent views within the EU institutions responsible for legislation.
Funding Information:
Conflicts of Interest: 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.
Publisher Copyright:
© 2022 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2022/2/1
Y1 - 2022/2/1
N2 - 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
AB - 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
U2 - 10.3390/ijerph19031674
DO - 10.3390/ijerph19031674
M3 - Article
SN - 1660-4601
VL - 19
SP - 1674
JO - International Journal of Environmental Research and Public Health
JF - International Journal of Environmental Research and Public Health
IS - 3
ER -