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External control arms in oncology: current use and future directions.
Mishra-Kalyani, P S; Amiri Kordestani, L; Rivera, D R; Singh, H; Ibrahim, A; DeClaro, R A; Shen, Y; Tang, S; Sridhara, R; Kluetz, P G; Concato, J; Pazdur, R; Beaver, J A.
Afiliação
  • Mishra-Kalyani PS; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA. Electronic address: pallavi.mishra-kalyani@fda.hhs.gov.
  • Amiri Kordestani L; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
  • Rivera DR; Oncology Center of Excellence, U.S, Food and Drug Administration, Silver Spring, USA.
  • Singh H; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA; Oncology Center of Excellence, U.S, Food and Drug Administration, Silver Spring, USA.
  • Ibrahim A; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
  • DeClaro RA; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA; Oncology Center of Excellence, U.S, Food and Drug Administration, Silver Spring, USA.
  • Shen Y; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
  • Tang S; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
  • Sridhara R; Oncology Center of Excellence, U.S, Food and Drug Administration, Silver Spring, USA.
  • Kluetz PG; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA; Oncology Center of Excellence, U.S, Food and Drug Administration, Silver Spring, USA.
  • Concato J; Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
  • Pazdur R; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA; Oncology Center of Excellence, U.S, Food and Drug Administration, Silver Spring, USA.
  • Beaver JA; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA; Oncology Center of Excellence, U.S, Food and Drug Administration, Silver Spring, USA.
Ann Oncol ; 33(4): 376-383, 2022 04.
Article em En | MEDLINE | ID: mdl-35026413

Texto completo: 1 Eixos temáticos: Pesquisa_clinica Base de dados: MEDLINE Assunto principal: Oncologia / Neoplasias Tipo de estudo: Clinical_trials Limite: Humans País como assunto: America do norte Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Eixos temáticos: Pesquisa_clinica Base de dados: MEDLINE Assunto principal: Oncologia / Neoplasias Tipo de estudo: Clinical_trials Limite: Humans País como assunto: America do norte Idioma: En Ano de publicação: 2022 Tipo de documento: Article