Selection bias, phase II trials, and the FDA accelerated approval process

Journal of the National Cancer Institute

Volumn 95, Issue 18, 2003, Pages 1351-1352

  George, Stephen L ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; DOCETAXEL; GEFITINIB; QUINAZOLINE DERIVATIVE;

ANALYSIS OF VARIANCE; ANALYTICAL ERROR; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CANCER THERAPY; CLINICAL STUDY; CLINICAL TRIAL; DEMOGRAPHY; DRUG APPROVAL; EDITORIAL; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; HEAD AND NECK CANCER; HEALTH CARE ACCESS; HUMAN; LUNG NON SMALL CELL CANCER; OUTCOMES RESEARCH; PATIENT SELECTION; PRIORITY JOURNAL; RANDOMIZATION; RELIABILITY; RISK BENEFIT ANALYSIS; SOCIOECONOMICS; EPIDEMIOLOGY; LUNG TUMOR; NEOPLASM; NOTE; PHASE 2 CLINICAL TRIAL; STANDARD; TREATMENT OUTCOME; UNITED STATES;

ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIALS, PHASE II; DRUG APPROVAL; HUMANS; LUNG NEOPLASMS; NEOPLASMS; QUINAZOLINES; SELECTION BIAS; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0141618270     PISSN: 00278874     EISSN: None     Source Type: Journal    
DOI: 10.1093/jnci/djg070     Document Type: Editorial

References (3)

1. Lamont EB, Hayreh D, Pickett KE, Dignam JJ, List MA, Stenson KM, et al. Is patient travel distance associated with survival on phase II clinical trials in oncology? J Natl Cancer Inst 2003;95:1370-5.
2. Hirschfeld S, Pazdur R. Oncology drug development: United States Food and Drug Administration perspective. Crit Rev Oncol Hematol 2002;42: 137-43.
3. U.S. Food and Drug Administration. Oncologic Drugs Advisory Committee Briefing Document. September 24, 2002. Available at: http://www.fda.gov/ohrms/dockets/ac/02/briefing/3894b1.htm. [Last accessed: August 11, 2003.]