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Data Safety and Monitoring Boards Should Be Required for Both Early- and Late-Phase Clinical Trials
Phase I and II clinical trials increasingly combine therapeutic and toxicity endpoints. Recently, therapeutic agents have even achieved U.S. Food and Drug Agency approval based on early phase trials alone. These developments point to new challenges in assuring the safety of human research subjects a...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Elsevier
2021
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8617574/ https://www.ncbi.nlm.nih.gov/pubmed/34869954 http://dx.doi.org/10.1016/j.jacbts.2021.09.005 |
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author | Van Norman, Gail A. |
author_facet | Van Norman, Gail A. |
author_sort | Van Norman, Gail A. |
collection | PubMed |
description | Phase I and II clinical trials increasingly combine therapeutic and toxicity endpoints. Recently, therapeutic agents have even achieved U.S. Food and Drug Agency approval based on early phase trials alone. These developments point to new challenges in assuring the safety of human research subjects and patients. Given their size and use of real-world patients, phase III studies warrant independent monitoring by a Drug Safety Monitoring Board (DSMB). Requirements should also be extended to include many phase I and II clinical trials. Measures should be taken to establish and standardize minimum qualifications for service on a DSMB. |
format | Online Article Text |
id | pubmed-8617574 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-86175742021-12-02 Data Safety and Monitoring Boards Should Be Required for Both Early- and Late-Phase Clinical Trials Van Norman, Gail A. JACC Basic Transl Sci Translational Toolbox Phase I and II clinical trials increasingly combine therapeutic and toxicity endpoints. Recently, therapeutic agents have even achieved U.S. Food and Drug Agency approval based on early phase trials alone. These developments point to new challenges in assuring the safety of human research subjects and patients. Given their size and use of real-world patients, phase III studies warrant independent monitoring by a Drug Safety Monitoring Board (DSMB). Requirements should also be extended to include many phase I and II clinical trials. Measures should be taken to establish and standardize minimum qualifications for service on a DSMB. Elsevier 2021-11-22 /pmc/articles/PMC8617574/ /pubmed/34869954 http://dx.doi.org/10.1016/j.jacbts.2021.09.005 Text en © 2021 The Author https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Translational Toolbox Van Norman, Gail A. Data Safety and Monitoring Boards Should Be Required for Both Early- and Late-Phase Clinical Trials |
title | Data Safety and Monitoring Boards Should Be Required for Both Early- and Late-Phase Clinical Trials |
title_full | Data Safety and Monitoring Boards Should Be Required for Both Early- and Late-Phase Clinical Trials |
title_fullStr | Data Safety and Monitoring Boards Should Be Required for Both Early- and Late-Phase Clinical Trials |
title_full_unstemmed | Data Safety and Monitoring Boards Should Be Required for Both Early- and Late-Phase Clinical Trials |
title_short | Data Safety and Monitoring Boards Should Be Required for Both Early- and Late-Phase Clinical Trials |
title_sort | data safety and monitoring boards should be required for both early- and late-phase clinical trials |
topic | Translational Toolbox |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8617574/ https://www.ncbi.nlm.nih.gov/pubmed/34869954 http://dx.doi.org/10.1016/j.jacbts.2021.09.005 |
work_keys_str_mv | AT vannormangaila datasafetyandmonitoringboardsshouldberequiredforbothearlyandlatephaseclinicaltrials |