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Design and evaluation of an external control arm using prior clinical trials and real-world data

IMPORTANCE: The use of existing data (real world data or prior trials) to design and analyze clinical studies has the potential to accelerate drug development processes and can contribute to rigorous examination of new treatments. OBJECTIVE: We discuss designs and interpretable metrics of bias and s...

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Publicado en:Clin Cancer Res
Autores principales: Ventz, Steffen, Lai, Albert, Cloughesy, Timothy F., Wen, Patrick Y., Trippa, Lorenzo, Alexander, Brian M.
Formato: Artigo
Lenguaje:Inglês
Publicado: 2019
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Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC6697596/
https://ncbi.nlm.nih.gov/pubmed/31175098
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1158/1078-0432.CCR-19-0820
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