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A roadmap to using historical controls in clinical trials – by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG)
Historical controls (HCs) can be used for model parameter estimation at the study design phase, adaptation within a study, or supplementation or replacement of a control arm. Currently on the latter, there is no practical roadmap from design to analysis of a clinical trial to address selection and i...
Autores principales: | Ghadessi, Mercedeh, Tang, Rui, Zhou, Joey, Liu, Rong, Wang, Chenkun, Toyoizumi, Kiichiro, Mei, Chaoqun, Zhang, Lixia, Deng, C. Q., Beckman, Robert A. |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7069184/ https://www.ncbi.nlm.nih.gov/pubmed/32164754 http://dx.doi.org/10.1186/s13023-020-1332-x |
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