Definitions and statistical properties of master protocols for personalized medicine in oncology.
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.
Palavras-chave
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