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Safety Surveillance During Drug Development: Comparative Evaluation of Existing Regulations
Drug safety monitoring is essential for developing efficient and safe treatments. It starts with preclinical toxicology studies and continues with the observation and analysis of potentially harmful effects in humans throughout the whole drug life cycle. Safety surveillance during the clinical phase...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10075498/ https://www.ncbi.nlm.nih.gov/pubmed/37020083 http://dx.doi.org/10.1007/s12325-023-02492-3 |
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author | Samara, Chrysanthi Garcia, Alix Henry, Christopher Vallotton, Laure Cariolato, Luca Desmeules, Jules Pinçon, Alexis |
author_facet | Samara, Chrysanthi Garcia, Alix Henry, Christopher Vallotton, Laure Cariolato, Luca Desmeules, Jules Pinçon, Alexis |
author_sort | Samara, Chrysanthi |
collection | PubMed |
description | Drug safety monitoring is essential for developing efficient and safe treatments. It starts with preclinical toxicology studies and continues with the observation and analysis of potentially harmful effects in humans throughout the whole drug life cycle. Safety surveillance during the clinical phase is of paramount importance for protecting the health of clinical trial (CT) participants at a period when relatively little is known about the drug safety profile, and for reassuring that detected risks are minimized when the product obtains marketing approval. This review aimed to investigate current safety surveillance methods during drug development worldwide, in order to identify potential gaps and opportunities for amelioration. To this end, international guidelines, standards, and local legislations about CTs were reviewed and compared. Our review revealed common strategies, mainly in alignment with international guidelines, especially concerning the systematic collection, assessment, and expedition of adverse events by investigators and sponsors and the preparation of periodic aggregate safety reports by sponsors, as a means to inform health authorities (HAs) about the evolving benefit–risk balance of the investigational product. Inconsistencies in safety surveillance mainly concerned local expedited reporting requirements. Significant gaps were identified in the methodologies for aggregate analyses and the responsibilities of HAs. Addressing the regulatory discrepancies and harmonizing the safety surveillance processes at a global level would increase the usability of safety data accumulated by clinical studies worldwide, thus enabling and hopefully accelerating the development of safe and efficient drug therapies. |
format | Online Article Text |
id | pubmed-10075498 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-100754982023-04-06 Safety Surveillance During Drug Development: Comparative Evaluation of Existing Regulations Samara, Chrysanthi Garcia, Alix Henry, Christopher Vallotton, Laure Cariolato, Luca Desmeules, Jules Pinçon, Alexis Adv Ther Review Drug safety monitoring is essential for developing efficient and safe treatments. It starts with preclinical toxicology studies and continues with the observation and analysis of potentially harmful effects in humans throughout the whole drug life cycle. Safety surveillance during the clinical phase is of paramount importance for protecting the health of clinical trial (CT) participants at a period when relatively little is known about the drug safety profile, and for reassuring that detected risks are minimized when the product obtains marketing approval. This review aimed to investigate current safety surveillance methods during drug development worldwide, in order to identify potential gaps and opportunities for amelioration. To this end, international guidelines, standards, and local legislations about CTs were reviewed and compared. Our review revealed common strategies, mainly in alignment with international guidelines, especially concerning the systematic collection, assessment, and expedition of adverse events by investigators and sponsors and the preparation of periodic aggregate safety reports by sponsors, as a means to inform health authorities (HAs) about the evolving benefit–risk balance of the investigational product. Inconsistencies in safety surveillance mainly concerned local expedited reporting requirements. Significant gaps were identified in the methodologies for aggregate analyses and the responsibilities of HAs. Addressing the regulatory discrepancies and harmonizing the safety surveillance processes at a global level would increase the usability of safety data accumulated by clinical studies worldwide, thus enabling and hopefully accelerating the development of safe and efficient drug therapies. Springer Healthcare 2023-04-05 2023 /pmc/articles/PMC10075498/ /pubmed/37020083 http://dx.doi.org/10.1007/s12325-023-02492-3 Text en © The Author(s) 2023 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 Samara, Chrysanthi Garcia, Alix Henry, Christopher Vallotton, Laure Cariolato, Luca Desmeules, Jules Pinçon, Alexis Safety Surveillance During Drug Development: Comparative Evaluation of Existing Regulations |
title | Safety Surveillance During Drug Development: Comparative Evaluation of Existing Regulations |
title_full | Safety Surveillance During Drug Development: Comparative Evaluation of Existing Regulations |
title_fullStr | Safety Surveillance During Drug Development: Comparative Evaluation of Existing Regulations |
title_full_unstemmed | Safety Surveillance During Drug Development: Comparative Evaluation of Existing Regulations |
title_short | Safety Surveillance During Drug Development: Comparative Evaluation of Existing Regulations |
title_sort | safety surveillance during drug development: comparative evaluation of existing regulations |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10075498/ https://www.ncbi.nlm.nih.gov/pubmed/37020083 http://dx.doi.org/10.1007/s12325-023-02492-3 |
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