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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...

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Autores principales: Samara, Chrysanthi, Garcia, Alix, Henry, Christopher, Vallotton, Laure, Cariolato, Luca, Desmeules, Jules, Pinçon, Alexis
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2023
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.
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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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