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Current Status, Challenges, and Future Perspectives of Real-World Data and Real-World Evidence in Japan
ABSTRACT: The aim of this article is to help develop a common understanding of the current status, challenges, and future perspectives of real-world data (RWD) and real-world evidence (RWE) in Japan. RWD and RWE are very widely used terms, but standardized definitions are lacking. Given broad and gr...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer International Publishing
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8605941/ https://www.ncbi.nlm.nih.gov/pubmed/34148219 http://dx.doi.org/10.1007/s40801-021-00266-3 |
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author | Hiramatsu, Katsutoshi Barrett, Annabel Miyata, Yasuhiko |
author_facet | Hiramatsu, Katsutoshi Barrett, Annabel Miyata, Yasuhiko |
author_sort | Hiramatsu, Katsutoshi |
collection | PubMed |
description | ABSTRACT: The aim of this article is to help develop a common understanding of the current status, challenges, and future perspectives of real-world data (RWD) and real-world evidence (RWE) in Japan. RWD and RWE are very widely used terms, but standardized definitions are lacking. Given broad and growing applications of RWD/RWE from the perspective of clinical development and medical affairs, the PhRMA Japan Medical Affairs Committee Working Group 1 have proposed the following definitions: “RWD are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources” and “RWE is the evidence derived from analysis of RWD.” The key challenges for RWD and RWE in Japan include restricted access and linkage of RWD, as well as a lack of universally accepted methodological approaches, which reduces the potential for patient and healthcare benefits. These challenges for RWD/RWE are by no means unique to Japan and similar challenges exist for countries in Europe and the USA. The quality of data and analysis, study design, and the transparency of reporting should be discussed more to ensure credibility and acceptance by decision-makers as the demand for RWD and RWE increases. The future developments around Japan’s RWD and RWE are expected to include improved RWD access, data linkage, and increased acceptance by decision-makers, all supported by innovative technology. Improvements in RWD access and database linkage will enable both public and private sectors to assemble more comprehensive health information in Japan. VIDEO ABSTRACT: SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40801-021-00266-3. |
format | Online Article Text |
id | pubmed-8605941 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-86059412021-11-24 Current Status, Challenges, and Future Perspectives of Real-World Data and Real-World Evidence in Japan Hiramatsu, Katsutoshi Barrett, Annabel Miyata, Yasuhiko Drugs Real World Outcomes Review Article ABSTRACT: The aim of this article is to help develop a common understanding of the current status, challenges, and future perspectives of real-world data (RWD) and real-world evidence (RWE) in Japan. RWD and RWE are very widely used terms, but standardized definitions are lacking. Given broad and growing applications of RWD/RWE from the perspective of clinical development and medical affairs, the PhRMA Japan Medical Affairs Committee Working Group 1 have proposed the following definitions: “RWD are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources” and “RWE is the evidence derived from analysis of RWD.” The key challenges for RWD and RWE in Japan include restricted access and linkage of RWD, as well as a lack of universally accepted methodological approaches, which reduces the potential for patient and healthcare benefits. These challenges for RWD/RWE are by no means unique to Japan and similar challenges exist for countries in Europe and the USA. The quality of data and analysis, study design, and the transparency of reporting should be discussed more to ensure credibility and acceptance by decision-makers as the demand for RWD and RWE increases. The future developments around Japan’s RWD and RWE are expected to include improved RWD access, data linkage, and increased acceptance by decision-makers, all supported by innovative technology. Improvements in RWD access and database linkage will enable both public and private sectors to assemble more comprehensive health information in Japan. VIDEO ABSTRACT: SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40801-021-00266-3. Springer International Publishing 2021-06-19 /pmc/articles/PMC8605941/ /pubmed/34148219 http://dx.doi.org/10.1007/s40801-021-00266-3 Text en © The Author(s) 2021, corrected publication 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Review Article Hiramatsu, Katsutoshi Barrett, Annabel Miyata, Yasuhiko Current Status, Challenges, and Future Perspectives of Real-World Data and Real-World Evidence in Japan |
title | Current Status, Challenges, and Future Perspectives of Real-World Data and Real-World Evidence in Japan |
title_full | Current Status, Challenges, and Future Perspectives of Real-World Data and Real-World Evidence in Japan |
title_fullStr | Current Status, Challenges, and Future Perspectives of Real-World Data and Real-World Evidence in Japan |
title_full_unstemmed | Current Status, Challenges, and Future Perspectives of Real-World Data and Real-World Evidence in Japan |
title_short | Current Status, Challenges, and Future Perspectives of Real-World Data and Real-World Evidence in Japan |
title_sort | current status, challenges, and future perspectives of real-world data and real-world evidence in japan |
topic | Review Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8605941/ https://www.ncbi.nlm.nih.gov/pubmed/34148219 http://dx.doi.org/10.1007/s40801-021-00266-3 |
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