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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...

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Autores principales: Acha, Virginia, Barefoot, Bart, Juarez Garcia, Ariadna, Lehner, Valerie, Monno, Raffaella, Sandler, Susan, Spooner, Almath, Verpillat, Patrice
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
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.
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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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