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Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples.
Amatya, Anup K; Fiero, Mallorie H; Bloomquist, Erik W; Sinha, Arup K; Lemery, Steven J; Singh, Harpreet; Ibrahim, Amna; Donoghue, Martha; Fashoyin-Aje, Lola A; de Claro, R Angelo; Gormley, Nicole J; Amiri-Kordestani, Laleh; Sridhara, Rajeshwari; Theoret, Marc R; Kluetz, Paul G; Pazdur, Richard; Beaver, Julia A; Tang, Shenghui.
Afiliação
  • Amatya AK; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Biostatistics, Silver Spring, Maryland. anup.amatya@fda.hhs.gov.
  • Fiero MH; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Biostatistics, Silver Spring, Maryland.
  • Bloomquist EW; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Biostatistics, Silver Spring, Maryland.
  • Sinha AK; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Biostatistics, Silver Spring, Maryland.
  • Lemery SJ; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.
  • Singh H; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland.
  • Ibrahim A; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.
  • Donoghue M; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland.
  • Fashoyin-Aje LA; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.
  • de Claro RA; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland.
  • Gormley NJ; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.
  • Amiri-Kordestani L; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland.
  • Sridhara R; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.
  • Theoret MR; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland.
  • Kluetz PG; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.
  • Pazdur R; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland.
  • Beaver JA; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.
  • Tang S; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland.
Clin Cancer Res ; 27(21): 5753-5756, 2021 11 01.
Article em En | MEDLINE | ID: mdl-34117032
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ensaios Clínicos como Assunto / Neoplasias / Antineoplásicos Tipo de estudo: Prognostic_studies / Risk_factors_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2021 Tipo de documento: Article
Texto completo
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XML
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ensaios Clínicos como Assunto / Neoplasias / Antineoplásicos Tipo de estudo: Prognostic_studies / Risk_factors_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2021 Tipo de documento: Article