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Use of RWE to Inform Regulatory, Public Health Policy, and Intervention Priorities for the Developing World

For low‐ and middle‐income countries (LMICs) to benefit from real‐world evidence (RWE)/real‐world data (RWD) in both product registration (“regulatory”) decision making and in product utilization policy (“policy”) decision making, they need to overcome several challenges. They need to deploy more el...

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Detalles Bibliográficos
Autores principales: McNair, Douglas, Lumpkin, Murray, Kern, Steven, Hartman, Daniel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9298255/
https://www.ncbi.nlm.nih.gov/pubmed/34655224
http://dx.doi.org/10.1002/cpt.2449
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author McNair, Douglas
Lumpkin, Murray
Kern, Steven
Hartman, Daniel
author_facet McNair, Douglas
Lumpkin, Murray
Kern, Steven
Hartman, Daniel
author_sort McNair, Douglas
collection PubMed
description For low‐ and middle‐income countries (LMICs) to benefit from real‐world evidence (RWE)/real‐world data (RWD) in both product registration (“regulatory”) decision making and in product utilization policy (“policy”) decision making, they need to overcome several challenges. They need to deploy more electronic health records systems (EHRs), adjust for confounder variables, build trust between stakeholders, and create laws and regulations for local generation of data that are assented for secondary use. The role of procurers and their use of RWE/RWD in the LMIC context likewise is in a state of ongoing development. Procurers of health products are strong players currently in the “access” chain as LMICs continue to work on strengthening governmental health technology assessment (HTA) bodies. Procurers’ use of RWE is presently at an early stage and is mostly indirect, leveraging RWE results that are produced by researchers in high‐income countries (HICs), often under considerably different regulatory and policy objectives and constraints compared to LMICs’ epidemiology and priorities. Pending wider deployment of EHRs and other RWE sources, stakeholders must realize that populations from HIC RWE (i) can be devised to closely resemble phenotypic patterns in LMIC populations and (ii) can be analyzed to align with LMICs’ unmet needs.
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spelling pubmed-92982552022-07-22 Use of RWE to Inform Regulatory, Public Health Policy, and Intervention Priorities for the Developing World McNair, Douglas Lumpkin, Murray Kern, Steven Hartman, Daniel Clin Pharmacol Ther Reviews For low‐ and middle‐income countries (LMICs) to benefit from real‐world evidence (RWE)/real‐world data (RWD) in both product registration (“regulatory”) decision making and in product utilization policy (“policy”) decision making, they need to overcome several challenges. They need to deploy more electronic health records systems (EHRs), adjust for confounder variables, build trust between stakeholders, and create laws and regulations for local generation of data that are assented for secondary use. The role of procurers and their use of RWE/RWD in the LMIC context likewise is in a state of ongoing development. Procurers of health products are strong players currently in the “access” chain as LMICs continue to work on strengthening governmental health technology assessment (HTA) bodies. Procurers’ use of RWE is presently at an early stage and is mostly indirect, leveraging RWE results that are produced by researchers in high‐income countries (HICs), often under considerably different regulatory and policy objectives and constraints compared to LMICs’ epidemiology and priorities. Pending wider deployment of EHRs and other RWE sources, stakeholders must realize that populations from HIC RWE (i) can be devised to closely resemble phenotypic patterns in LMIC populations and (ii) can be analyzed to align with LMICs’ unmet needs. John Wiley and Sons Inc. 2021-10-31 2022-01 /pmc/articles/PMC9298255/ /pubmed/34655224 http://dx.doi.org/10.1002/cpt.2449 Text en © 2021 Bill & Melinda Gates Foundation. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Reviews
McNair, Douglas
Lumpkin, Murray
Kern, Steven
Hartman, Daniel
Use of RWE to Inform Regulatory, Public Health Policy, and Intervention Priorities for the Developing World
title Use of RWE to Inform Regulatory, Public Health Policy, and Intervention Priorities for the Developing World
title_full Use of RWE to Inform Regulatory, Public Health Policy, and Intervention Priorities for the Developing World
title_fullStr Use of RWE to Inform Regulatory, Public Health Policy, and Intervention Priorities for the Developing World
title_full_unstemmed Use of RWE to Inform Regulatory, Public Health Policy, and Intervention Priorities for the Developing World
title_short Use of RWE to Inform Regulatory, Public Health Policy, and Intervention Priorities for the Developing World
title_sort use of rwe to inform regulatory, public health policy, and intervention priorities for the developing world
topic Reviews
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9298255/
https://www.ncbi.nlm.nih.gov/pubmed/34655224
http://dx.doi.org/10.1002/cpt.2449
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