Empowering quality data – the gordian knot of bringing real innovation into healthcare system

Author:

Horgan Denis12,Hamdi Yosr34,Lal Jonathan A.25,Nyawira Teresia6,Meyer Salomé7,Kondji Dominique8,Francisco Ngiambudulu M.9,De Guzman Roselle10,Paul Anupriya11,Nallamalla Krishna Reddy12,Park Woong-Yang13,Triapthi Vijay2,Tripathi Ravikant14,Johns Amber15,Singh Mohan P.16,Phipps Maude E.17,Dube France18,Abu Rasheed Hadi Mohamad19,Kozaric Marta1,Pinto Joseph A.20,Stefani Stephen Doral21,Aponte Rueda Maria Eugenia22,Alarcon Ricardo Fujita23,Barrera-Saldana Hugo A.2425

Affiliation:

1. European Alliance for Personalised Medicine , Brussels , Belgium

2. Department of Molecular and Cellular Engineering , Jacob Institute of Biotechnology and Bioengineering Sam Higginbottom University of Agriculture, Technology and Sciences Prayagraj , India

3. Laboratory of Biomedical Genomics and Oncogenetics, Institut Pasteur de Tunis, University of Tunis El Manar , Tunis , Tunisia

4. Laboratory of Human and Experimental Pathology, Institut Pasteur de Tunis , Tunis , Tunisia

5. Department of Genetics and Cell Biology, GROW School of Oncology and Developmental Biology, Faculty of Health, Medicine and Life Sciences , Institute for Public Health Genomics, Maastricht University , Maastricht , Netherlands

6. National Commission for Science, Technology and Innovation in Kenya (NACOSTI) , Nairobi Kenya , Kenya

7. Cancer Alliance , Cape Town , South Africa

8. Health & Development Communication, Building Capacity for Better Health in Africa Building Capacities for Better Health in AFRICA , Yaounde , Cameroun

9. Grupo de Investigação Microbiana e Imunológica , Instituto Nacional de Investigação em Saúde (National Institute for Health Research) , Luanda , Angola

10. Oncology and Pain Management Section, Manila Central University–Filemon D. Tanchoco Medical Foundation Hospital , Caloocan City , Philippines

11. Department of Mathematics and Statistics, Faculty of Science , Sam Higginbottom University of Agriculture, Technology and Sciences , Prayagraj , India

12. ACCESS Health India , Hyderabad , India

13. Samsung Genome Institute, Samsung Medical Center, Sungkyunkwan University , Seoul , Korea

14. Department Health Govt of India , Ministry of labor , New Delhi , India

15. Garvan Institute of Medical Research and The Kinghorn Cancer Centre, Cancer Division , Sydney , Australia

16. Center of Biotechnology, University of Allahabad , Allahabad , India

17. Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Jalan Lagoon Selatan , Bandar Sunway , Selangor , Malaysia

18. Astra Zeneca, Concord Pike , Wilmington , DE , USA

19. Qatar Cancer Society , Doha , Qatar

20. Center for Basic and Translational Research, Auna Ideas , Lima , Peru

21. UNIMED RS , Porto Alegre , Brazil

22. Venezuelan Breast Cancer Research and Education Foundation , Caracas , Venezuela

23. Centro de Genética y Biología Molecular, Universidad de San Martín de Porres , Lima , Perú

24. Innbiogem SC/Vitagenesis SA at National Laboratory for Services of Research, Development, and Innovation for the Pharma and Biotech Industries (LANSEIDI) of CONACyT Vitaxentrum Group , Monterrey , Mexico

25. Schools of Medicine and Biology, Autonomous University of Nuevo Leon , Monterrey , Mexico

Abstract

Abstract Objectives The introduction of Personalised Medicine (PM) into healthcare systems could benefit from a clearer understanding of the distinct national and regional frameworks around the world. Recent engagement by international regulators on maximising the use of real-world evidence (RWE) has highlighted the scope for improving the exploitation of the treasure-trove of health data that is currently largely neglected in many countries. The European Alliance for Personalised Medicine (EAPM) led an international study aimed at identifying the current status of conditions. Methods A literature review examined how far such frameworks exist, with a view to identifying conducive factors – and crucial gaps. This extensive review of key factors across 22 countries and 5 regions revealed a wide variety of attitudes, approaches, provisions and conditions, and permitted the construction of a comprehensive overview of the current status of PM. Based on seven key pillars identified from the literature review and expert panels, the data was quantified, and on the basis of further analysis, an index was developed to allow comparison country by country and region by region. Results The results show that United States of America is leading according to overall outcome whereas Kenya scored the least in the overall outcome. Conclusions Still, common approaches exist that could help accelerate take-up of opportunities even in the less prosperous parts of the world.

Publisher

Walter de Gruyter GmbH

Subject

Biochemistry (medical),Clinical Biochemistry,Public Health, Environmental and Occupational Health,Health Policy,Medicine (miscellaneous)

Reference147 articles.

1. ICMRA. ICMRA statement on international collaboration to enable real-world evidence (RWE) for regulatory decision-making; 2022. Available from: https://www.icmra.info/drupal/sites/default/files/2022-07/icmra_statement_on_rwe.pdf [Accessed 25 Jul 2022].

2. ICMRA. A draft policy paper for ICMRA pharmacovigilance project; 2016. Available from: https://icmra.info/drupal/sites/default/files/2018-02/ICMRA%20PhV%20Big%20Data%20SubWG%20Policy%20Paper.pdf.

3. European Commission. European health data space; 2022. Available from: https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en [Accessed 25 Jul 2022].

4. Jauregui, AE. Overview of the European health data space (EHDS): goals and current challenges. Eur J Publ Health 2021;31:ckab164.123. https://doi.org/10.1093/eurpub/ckab164.123. https://doi.org/10.1093/eurpub/ckab164.123.

5. Shabani, M. Will the European Health Data Space change data sharing rules? Science 2022;375:1357–9. https://doi.org/10.1126/science.abn4874.

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