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Definitions and statistical properties of master protocols for personalized medicine in oncology.
Renfro, Lindsay A; Mandrekar, Sumithra J.
Afiliação
  • Renfro LA; a Division of Biomedical Statistics and Informatics , Mayo Clinic , Rochester , MN , USA.
  • Mandrekar SJ; a Division of Biomedical Statistics and Informatics , Mayo Clinic , Rochester , MN , USA.
J Biopharm Stat ; 28(2): 217-228, 2018.
Article em En | MEDLINE | ID: mdl-28877008
Within the field of cancer research, discovery of biomarkers and genetic mutations that are potentially predictive of treatment benefit is motivating a paradigm shift in how cancer clinical trials are conducted. In this review, we provide an overview of the class of trials known as "master protocols," including basket trials, umbrella trials, and platform trials. For each, we describe standardized terminology, provide a motivating example with modeling details and decision rules, and discuss statistical advantages and limitations. We conclude with a discussion of general statistical considerations and challenges encountered across these types of trials.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Projetos de Pesquisa / Biomarcadores Tumorais / Medicina de Precisão / Protocolos de Ensaio Clínico como Assunto / Oncologia / Neoplasias Tipo de estudo: Guideline / Prognostic_studies Limite: Humans Idioma: En Ano de publicação: 2018 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Projetos de Pesquisa / Biomarcadores Tumorais / Medicina de Precisão / Protocolos de Ensaio Clínico como Assunto / Oncologia / Neoplasias Tipo de estudo: Guideline / Prognostic_studies Limite: Humans Idioma: En Ano de publicação: 2018 Tipo de documento: Article