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Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers
This reflection paper presents a consolidated view of EFPIA on the need for principles for good practice in the generation and use of non-interventional studies (NIS), including overarching principles such as the registration of hypothesis evaluating treatment effect (HETE) studies. We first define...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10579109/ https://www.ncbi.nlm.nih.gov/pubmed/37460826 http://dx.doi.org/10.1007/s43441-023-00544-y |
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author | Acha, Virginia Barefoot, Bart Juarez Garcia, Ariadna Lehner, Valerie Monno, Raffaella Sandler, Susan Spooner, Almath Verpillat, Patrice |
author_facet | Acha, Virginia Barefoot, Bart Juarez Garcia, Ariadna Lehner, Valerie Monno, Raffaella Sandler, Susan Spooner, Almath Verpillat, Patrice |
author_sort | Acha, Virginia |
collection | PubMed |
description | This reflection paper presents a consolidated view of EFPIA on the need for principles for good practice in the generation and use of non-interventional studies (NIS), including overarching principles such as the registration of hypothesis evaluating treatment effect (HETE) studies. We first define NIS and the important adjacencies to clinical trials and relationship with real-world evidence (RWE). We then outline the principles for good practice with respect to appropriate research design, study protocol, fit-for-purpose variables and data quality, analytical methods, bias reduction, transparency in conduct and use, privacy management and ethics review. We conclude with recommendations for action for the research community to promote trust and credibility in the use of NIS. |
format | Online Article Text |
id | pubmed-10579109 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-105791092023-10-18 Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers Acha, Virginia Barefoot, Bart Juarez Garcia, Ariadna Lehner, Valerie Monno, Raffaella Sandler, Susan Spooner, Almath Verpillat, Patrice Ther Innov Regul Sci Original Research This reflection paper presents a consolidated view of EFPIA on the need for principles for good practice in the generation and use of non-interventional studies (NIS), including overarching principles such as the registration of hypothesis evaluating treatment effect (HETE) studies. We first define NIS and the important adjacencies to clinical trials and relationship with real-world evidence (RWE). We then outline the principles for good practice with respect to appropriate research design, study protocol, fit-for-purpose variables and data quality, analytical methods, bias reduction, transparency in conduct and use, privacy management and ethics review. We conclude with recommendations for action for the research community to promote trust and credibility in the use of NIS. Springer International Publishing 2023-07-17 2023 /pmc/articles/PMC10579109/ /pubmed/37460826 http://dx.doi.org/10.1007/s43441-023-00544-y Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits 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/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Original Research Acha, Virginia Barefoot, Bart Juarez Garcia, Ariadna Lehner, Valerie Monno, Raffaella Sandler, Susan Spooner, Almath Verpillat, Patrice Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers |
title | Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers |
title_full | Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers |
title_fullStr | Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers |
title_full_unstemmed | Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers |
title_short | Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers |
title_sort | principles for good practice in the conduct of non-interventional studies: the view of industry researchers |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10579109/ https://www.ncbi.nlm.nih.gov/pubmed/37460826 http://dx.doi.org/10.1007/s43441-023-00544-y |
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