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Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop.
Kluetz, Paul G; Kanapuru, Bindu; Lemery, Steven; Johnson, Laura Lee; Fiero, Mallorie H; Arscott, Karen; Barbachano, Yolanda; Basch, Ethan; Campbell, Michelle; Cappelleri, Joseph C; Cella, David; Cleeland, Charles; Coens, Corneel; Daniels, Selena; Denlinger, Crystal S; Fairclough, Dianne L; Hillard, James R; Minasian, Lori; Mitchell, Sandra A; O'Connor, Daniel; Patel, Sheetal; Rubin, Eric H; Ryden, Anna; Soltys, Katherine; Sridhara, Rajeshwari; Thanarajasingam, Gita; Velikova, Galina; Coons, Stephen Joel.
Afiliação
  • Kluetz PG; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA. Electronic address: paul.kluetz@fda.hhs.gov.
  • Kanapuru B; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Lemery S; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Johnson LL; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Fiero MH; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Arscott K; Geisinger Commonwealth School of Medicine, Scranton, PA, USA.
  • Barbachano Y; Medicines and Healthcare Products Regulatory Agency, Victoria, London, UK.
  • Basch E; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
  • Campbell M; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Cappelleri JC; Pfizer Inc., Groton, CT, USA.
  • Cella D; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL, USA.
  • Cleeland C; Department of Symptom Research, Division of Internal Medicine, UT MD Anderson Cancer Center, Houston, TX, USA.
  • Coens C; European Organisation for Research and Treatment of Cancer (EORTC) HQ, Quality of Life Department, Brussels, Belgium.
  • Daniels S; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Denlinger CS; Fox Chase Cancer Center, Philadelphia, PA, USA.
  • Fairclough DL; Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, CO, USA.
  • Hillard JR; Patient Representative, East Lansing, MI, USA.
  • Minasian L; National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
  • Mitchell SA; National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
  • O'Connor D; Medicines and Healthcare Products Regulatory Agency, Victoria, London, UK.
  • Patel S; Genentech, South San Francisco, CA, USA.
  • Rubin EH; Merck Research Laboratories, Merck & Co., Kenilworth, NJ, USA.
  • Ryden A; AstraZeneca, Gothenburg, Sweden.
  • Soltys K; Therapeutic Products Directorate, Health Products and Food Branch, Health Canada, Ottawa, ON, Canada.
  • Sridhara R; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Thanarajasingam G; Division of Hematology, Mayo Clinic, Rochester, MN, USA.
  • Velikova G; Leeds Institute of Cancer and Pathology, University of Leeds, St James's Institute of Oncology, Leeds, UK.
  • Coons SJ; Patient-Reported Outcome Consortium, Critical Path Institute, Tucson, AZ, USA.
Value Health ; 21(6): 742-747, 2018 06.
Article em En | MEDLINE | ID: mdl-29909880
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: United States Food and Drug Administration / Neoplasias Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2018 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: United States Food and Drug Administration / Neoplasias Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2018 Tipo de documento: Article