Current perspectives for external control arms in oncology clinical trials: Analysis of EMA approvals 2016-2021.

Wang, Xiaomeng; Dormont, Flavio; Lorenzato, Christelle; Latouche, Aurélien; Hernandez, Ramon; Rouzier, Roman

Wang, Xiaomeng; Dormont, Flavio; Lorenzato, Christelle; Latouche, Aurélien; Hernandez, Ramon; Rouzier, Roman.

Afiliação

Wang X; INSERM, U900, Institut Curie, PSL Research University, Saint-Cloud, France; Department of Research and Development, Sanofi, Chilly-Mazarin, France. Electronic address: xiaomeng.wang@curie.fr.
Dormont F; Department of Research and Development, Sanofi, Chilly-Mazarin, France.
Lorenzato C; Department of Research and Development, Sanofi, Chilly-Mazarin, France.
Latouche A; INSERM, U900, Institut Curie, PSL Research University, Saint-Cloud, France; Conservatoire National des Arts et Métiers, Paris, France.
Hernandez R; Department of Research and Development, Sanofi, Chilly-Mazarin, France.
Rouzier R; Department of Surgical Oncology, Centre François Baclesse, Caen, France.

J Cancer Policy ; 35: 100403, 2023 03.

Article em En | MEDLINE | ID: mdl-36646208

Assuntos

Antineoplásicos; Neoplasias; Humanos; Estudos Prospectivos; Neoplasias/tratamento farmacológico; Antineoplásicos/uso terapêutico; Oncologia; Aprovação de Drogas/métodos

Palavras-chave

Clinical trial; External control; Historical control; Oncology; Real-world data

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Texto completo: 1 Coleções: 01-internacional Contexto em Saúde: 1_ASSA2030 / 2_ODS3 Base de dados: MEDLINE Assunto principal: Neoplasias / Antineoplásicos Tipo de estudo: Guideline / Observational_studies / Prognostic_studies Limite: Humans Idioma: En Revista: J Cancer Policy Ano de publicação: 2023 Tipo de documento: Article

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