CANCER DIAGNOSIS;
CANCER GENETICS;
CANCER THERAPY;
CONFERENCE PAPER;
DIAGNOSTIC TEST;
DRUG APPROVAL;
DRUG TARGETING;
GENETIC ANALYSIS;
GOVERNMENT REGULATION;
HEALTH CARE COST;
HEALTH CARE QUALITY;
HUMAN;
LUNG NON SMALL CELL CANCER;
MASS COMMUNICATION;
MELANOMA;
MOLECULARLY TARGETED THERAPY;
PATIENT ADVOCACY;
PATIENT ATTITUDE;
PATIENT CARE;
PERSONALIZED MEDICINE;
PRIORITY JOURNAL;
PROCESS DEVELOPMENT;
PROGNOSIS;
REIMBURSEMENT;
RISK ASSESSMENT;
TREATMENT PLANNING;
FDA Approved Drug Products: Crizotinib. Available from: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index. cfm?fuseaction=Search.DrugDetails.
Reports from the 2010 Clinical and Translational Cancer Research Think Tank meeting: Design strategies for personalized therapy trials
Berry DA, Herbst RS, Rubin EH. Reports from the 2010 Clinical and Translational Cancer Research Think Tank meeting: design strategies for personalized therapy trials. Clin Cancer Res 2012;18:638-44.
July 14, 2011. Silver Spring (MD): U.S. Department of Health and Human Services, Food and Drug Administration
Draft guidance for industry and Food and Drug Administration staff: In vitro companion diagnostic devices. July 14, 2011. Silver Spring (MD): U.S. Department of Health and Human Services, Food and Drug Administration; 2011.
Driving biomedical innovation: initiatives to improve products for patients. U.S. Food and Drug Administration. [cited 2011 Oct]. Available from: http://www.fda.gov/AboutFDA/ReportsManualsForms/ Reports/ucm274333.htm
Integrating predictive biomarkers and classifiers into oncology clinical development programmes
Beckman RA, Clark J, Chen C. Integrating predictive biomarkers and classifiers into oncology clinical development programmes. Nat Rev Drug Discov 2011;10:735-48.
