ACUTE GRANULOCYTIC LEUKEMIA;
ANOREXIA;
CANCER CHEMOTHERAPY;
CANCER GROWTH;
CANCER RISK;
CANCER STAGING;
CANCER SURVIVAL;
CHRONIC MYELOID LEUKEMIA;
CLINICAL TRIAL;
COMBINATION CHEMOTHERAPY;
CONFERENCE PAPER;
CONTROLLED STUDY;
COUGHING;
DRUG APPROVAL;
DRUG EFFICACY;
DRUG MEGADOSE;
DYSPNEA;
ESOPHAGUS CANCER;
FATIGUE;
FOLLOW UP;
FOOD AND DRUG ADMINISTRATION;
HEAD AND NECK CANCER;
HEMOPTYSIS;
HOARSENESS;
HODGKIN DISEASE;
HUMAN;
INSOMNIA;
LOW DRUG DOSE;
LUNG NON SMALL CELL CANCER;
LUNG SMALL CELL CANCER;
LYMPHATIC LEUKEMIA;
MONOTHERAPY;
MUCOSA INFLAMMATION;
MULTIPLE MYELOMA;
NONHODGKIN LYMPHOMA;
PAIN;
PANCREAS CANCER;
PRIORITY JOURNAL;
PROSTATE CANCER;
QUALITY OF LIFE;
THORAX PAIN;
TREATMENT OUTCOME;
TREATMENT RESPONSE;
TUMOR GROWTH;
XEROSTOMIA;
ANTINEOPLASTIC AGENTS;
CLINICAL TRIALS AS TOPIC;
DRUG APPROVAL;
HUMANS;
NEOPLASMS;
PATIENT SATISFACTION;
QUALITY INDICATORS, HEALTH CARE;
QUALITY OF LIFE;
SICKNESS IMPACT PROFILE;
TREATMENT OUTCOME;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
US Food and Drug Administration: Guidance for Industry. Patient-reported outcome measures: Use in medical product development to support labeling claims. http://www.fda.gov/cder/guidance/5460dft.pdf
and Drug Administration: trial end points for the approval of cancer drugs and biologics
US Food and Drug Administration: Draft FDA Guidance for Industry: Clinical trial end points for the approval of cancer drugs and biologics. http://www.fda.gov/cder/guidance/6592dft.pdf
End points and United States Food and Drug Administration approval of oncology drugs
Johnson JR, Williams G, Pazdur R: End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol 21:1404-1411, 2003
Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials
O'Shaughnessy JA, Wittes RE, Burke G, et al: Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials. J Clin Oncol 9:2225-2232, 1991
Approval summary for imatinib mesylate capsules in the treatment of chronic myelogenous leukemia
Cohen MH, Williams G, Johnson JR, et al: Approval summary for imatinib mesylate capsules in the treatment of chronic myelogenous leukemia. Clin Cancer Res 8:935-942, 2002
Pazdur R: U.S. Food and Drug Administration Drug Approval Summary.Cohen MH, Johnson JR, Conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approval. Clin Cancer Res 11:12-19, 2005
Pazdur R: U.S. Food and Drug Administration Drug Approval Summary.Cohen MH, Johnson JR, Conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approval. Clin Cancer Res 11:12-19, 2005
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and Drug Administration
US Food and Drug Administration: Kepivance product label. http://www.fda.gov/cder/foi/label/2005/125103s0010lbl.pdf
Challenges to use of health-related quality-of-life for FDA approval of anticancer products
in press
Rock EP, Scott JA, Kennedy DL, et al: Challenges to use of health-related quality-of-life for FDA approval of anticancer products. J Natl Cancer Inst (in press)