Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials-Response.
Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. paul.kluetz@fda.hhs.gov.
Paul G
PG
Kluetz
Clinical Outcome Assessment Staff, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Elektra J
EJ
Papadopoulos
Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Laura Lee
LL
Johnson
Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Martha
M
Donoghue
Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Virginia E
VE
Kwitkowski
Clinical Outcome Assessment Staff, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Wen-Hung
WH
Chen
Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Rajeshwari
R
Sridhara
Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Ann T
AT
Farrell
Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Patricia
P
Keegan
Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Geoffrey
G
Kim
Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Richard
R
Pazdur
D002986:Clinical Trials as Topic; D023381:Endpoint Determination; D006801:Humans; D009369:Neoplasms; D000071066:Patient Reported Outcome Measures; D012107:Research Design; D016896:Treatment Outcome