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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...

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Detalles Bibliográficos
Autores principales: Ghadessi, Mercedeh, Tang, Rui, Zhou, Joey, Liu, Rong, Wang, Chenkun, Toyoizumi, Kiichiro, Mei, Chaoqun, Zhang, Lixia, Deng, C. Q., Beckman, Robert A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
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