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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 |