Empowering quality data - the Gordian knot of bringing real innovation into healthcare system

Denis Horgan^{1

2}, Yosr Hamdi^{3

4}, Jonathan A Lal^{2

5}, Teresia Nyawira⁶, Salomé Meyer⁷, Dominique Kondji⁸, Ngiambudulu M Francisco⁹, Roselle De Guzman¹⁰, Anupriya Paul¹¹, Krishna Reddy Nallamalla¹², Woong-Yang Park¹³, Vijay Triapthi², Ravikant Tripathi¹⁴, Amber Johns¹⁵, Mohan P Singh¹⁶, Maude E Phipps¹⁷, France Dube¹⁸, Hadi Mohamad Abu Rasheed¹⁹, Marta Kozaric¹, Joseph A Pinto²⁰, Stephen Doral Stefani²¹, Maria Eugenia Aponte Rueda²², Ricardo Fujita Alarcon²³, Hugo A Barrera-Saldana^{24

25}

Affiliations

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.

PMID: 36548810
DOI: 10.1515/dx-2022-0115

Review

Empowering quality data - the Gordian knot of bringing real innovation into healthcare system

Denis Horgan et al. Diagnosis (Berl). 2022.

. 2022 Dec 22;10(2):140-157.

doi: 10.1515/dx-2022-0115. eCollection 2023 May 1.

Authors

Affiliations

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.

PMID: 36548810
DOI: 10.1515/dx-2022-0115

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.

Keywords: cancer; empowerment; health data; infrastructure; personalized medicine; policy framework; public trust; real world evidence.

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References

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_statemen... [Accessed 25 Jul 2022].
1. ICMRA . A draft policy paper for ICMRA pharmacovigilance project ; 2016. Available from: https://icmra.info/drupal/sites/default/files/2018-02/ICMRA%20PhV%20Big%... .
1. European Commission . European health data space ; 2022. Available from: https://health.ec.europa.eu/ehealth-digital-health-and-care/european-hea... [Accessed 25 Jul 2022].
1. 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 . - DOI
1. Shabani, M. Will the European Health Data Space change data sharing rules? Science 2022;375:1357–9. https://doi.org/10.1126/science.abn4874 . - DOI

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Empowering quality data - the Gordian knot of bringing real innovation into healthcare system

Affiliations

Empowering quality data - the Gordian knot of bringing real innovation into healthcare system

Authors

Affiliations

Abstract

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

Medical