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Single-Arm Trials with External Comparators and Confounder Misclassification: How Adjustment Can Fail

BACKGROUND: “Single-arm trials” with external comparators that contrast outcomes in those on experimental therapy to real-world patients have been used to evaluate efficacy and safety of experimental drugs in rare and severe diseases. Regulatory agencies are considering expanding the role these stud...

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Detalhes bibliográficos
Publicado no:Med Care
Main Authors: Webster-Clark, Michael, Funk, Michele Jonsson, Stürmer, Til
Formato: Artigo
Idioma:Inglês
Publicado em: 2020
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7665993/
https://ncbi.nlm.nih.gov/pubmed/32925456
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1097/MLR.0000000000001400
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