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Real-world evidence for regulatory decision-making: updated guidance from around the world
Leveraging the value of real-world evidence (RWE) to make informed regulatory decisions in the field of health care continues to gain momentum. Improving clinical evidence generation by evaluating the outcomes and patient experiences at the point-of-care would help achieve the ultimate aim of ensuri...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10643567/ https://www.ncbi.nlm.nih.gov/pubmed/38020096 http://dx.doi.org/10.3389/fmed.2023.1236462 |
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author | Burns, Leah Le Roux, Nadege Kalesnik-Orszulak, Robert Christian, Jennifer Dudinak, Jennifer Rockhold, Frank Khozin, Sean O’Donnell, John |
author_facet | Burns, Leah Le Roux, Nadege Kalesnik-Orszulak, Robert Christian, Jennifer Dudinak, Jennifer Rockhold, Frank Khozin, Sean O’Donnell, John |
author_sort | Burns, Leah |
collection | PubMed |
description | Leveraging the value of real-world evidence (RWE) to make informed regulatory decisions in the field of health care continues to gain momentum. Improving clinical evidence generation by evaluating the outcomes and patient experiences at the point-of-care would help achieve the ultimate aim of ensuring that effective and safe treatments are rapidly approved for patient use. In our previous publication, we assessed the global regulatory landscape with respect to RWE and provided a review of the regional availability of frameworks and guidance through May 2021 on the basis of 3 key regulatory elements: regulatory RWE frameworks, data quality guidance, and study methods guidance. In the current review, we have updated and elaborated upon recent developments in the regulatory RWE environment from a regional perspective under the same 3 regulatory elements stated above. In addition, we have also included a new category on procedural guidance. The review also discusses the perceived gaps and potential opportunities for future development and harmonization in this field to support framework establishment in regions without pre-existing RWE policies. Additionally, the article reviews current developments of health technology assessment (HTA) bodies pertaining to RWE and discusses the status of evidentiary alignment among regulators and HTA agencies. |
format | Online Article Text |
id | pubmed-10643567 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-106435672023-10-30 Real-world evidence for regulatory decision-making: updated guidance from around the world Burns, Leah Le Roux, Nadege Kalesnik-Orszulak, Robert Christian, Jennifer Dudinak, Jennifer Rockhold, Frank Khozin, Sean O’Donnell, John Front Med (Lausanne) Medicine Leveraging the value of real-world evidence (RWE) to make informed regulatory decisions in the field of health care continues to gain momentum. Improving clinical evidence generation by evaluating the outcomes and patient experiences at the point-of-care would help achieve the ultimate aim of ensuring that effective and safe treatments are rapidly approved for patient use. In our previous publication, we assessed the global regulatory landscape with respect to RWE and provided a review of the regional availability of frameworks and guidance through May 2021 on the basis of 3 key regulatory elements: regulatory RWE frameworks, data quality guidance, and study methods guidance. In the current review, we have updated and elaborated upon recent developments in the regulatory RWE environment from a regional perspective under the same 3 regulatory elements stated above. In addition, we have also included a new category on procedural guidance. The review also discusses the perceived gaps and potential opportunities for future development and harmonization in this field to support framework establishment in regions without pre-existing RWE policies. Additionally, the article reviews current developments of health technology assessment (HTA) bodies pertaining to RWE and discusses the status of evidentiary alignment among regulators and HTA agencies. Frontiers Media S.A. 2023-10-30 /pmc/articles/PMC10643567/ /pubmed/38020096 http://dx.doi.org/10.3389/fmed.2023.1236462 Text en Copyright © 2023 Burns, Le Roux, Kalesnik-Orszulak, Christian, Dudinak, Rockhold, Khozin and O’Donnell. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Medicine Burns, Leah Le Roux, Nadege Kalesnik-Orszulak, Robert Christian, Jennifer Dudinak, Jennifer Rockhold, Frank Khozin, Sean O’Donnell, John Real-world evidence for regulatory decision-making: updated guidance from around the world |
title | Real-world evidence for regulatory decision-making: updated guidance from around the world |
title_full | Real-world evidence for regulatory decision-making: updated guidance from around the world |
title_fullStr | Real-world evidence for regulatory decision-making: updated guidance from around the world |
title_full_unstemmed | Real-world evidence for regulatory decision-making: updated guidance from around the world |
title_short | Real-world evidence for regulatory decision-making: updated guidance from around the world |
title_sort | real-world evidence for regulatory decision-making: updated guidance from around the world |
topic | Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10643567/ https://www.ncbi.nlm.nih.gov/pubmed/38020096 http://dx.doi.org/10.3389/fmed.2023.1236462 |
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