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Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.
Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G.
Affiliation
  • Basch E; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill.
  • Geoghegan C; Patient and Partners LLC, Madison, Connecticut.
  • Coons SJ; Patient-Reported Outcome Consortium, Critical Path Institute, Tucson, Arizona.
  • Gnanasakthy A; Novartis Pharmaceuticals, East Hanover, New Jersey.
  • Slagle AF; Study Endpoints Team, Study Endpoints and Labeling Development, Office of New Drugs, Immediate Office, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Papadopoulos EJ; Study Endpoints Team, Study Endpoints and Labeling Development, Office of New Drugs, Immediate Office, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Kluetz PG; Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
JAMA Oncol ; 1(3): 375-9, 2015 Jun.
Article de En | MEDLINE | ID: mdl-26181187
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Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Patients / Perception / Food and Drug Administration (USA) / Agrément de médicaments / Industrie pharmaceutique / Découverte de médicament / Tumeurs / Antinéoplasiques Type d'étude: Clinical_trials / Guideline / Prognostic_studies Aspects: Patient_preference Limites: Humans Pays/Région comme sujet: America do norte Langue: En Journal: JAMA Oncol Année: 2015 Type de document: Article Pays de publication: États-Unis d'Amérique
Texte intégral
Ajouter à My VHL
Imprimer
XML
PubMed Links
Recherche sur Google

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Patients / Perception / Food and Drug Administration (USA) / Agrément de médicaments / Industrie pharmaceutique / Découverte de médicament / Tumeurs / Antinéoplasiques Type d'étude: Clinical_trials / Guideline / Prognostic_studies Aspects: Patient_preference Limites: Humans Pays/Région comme sujet: America do norte Langue: En Journal: JAMA Oncol Année: 2015 Type de document: Article Pays de publication: États-Unis d'Amérique