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Methods for external control groups for single arm trials or long‐term uncontrolled extensions to randomized clinical trials

PURPOSE: Clinical trials compare outcomes among patients receiving study treatment with comparators drawn from the same source. These internal controls are missing in single arm trials and from long‐term extensions (LTE) of trials including only the treatment arm. An external control group derived f...

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Detalles Bibliográficos
Autores principales: Seeger, John D., Davis, Kourtney J., Iannacone, Michelle R., Zhou, Wei, Dreyer, Nancy, Winterstein, Almut G., Santanello, Nancy, Gertz, Barry, Berlin, Jesse A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756307/
https://www.ncbi.nlm.nih.gov/pubmed/32964514
http://dx.doi.org/10.1002/pds.5141