Clinical trials in the era of personalized oncology.
The rapid pace of discoveries in tumor biology, imaging technology, and human genetics hold promise for an era of personalized oncology care. The successful development of a handful of new targeted agents has generated much hope and hype about the delivery of safer and more effective new treatments for cancer. The design and conduct of clinical trials has not yet adjusted to a new era of personalized oncology and so we are more in transition to that era than in it. With the development of treatments for breast cancer as a model, we review the approaches to clinical trials and the development of novel therapeutics in the prior era of population oncology, the current transitional era, and the future era of personalized oncology.
Section of Hematology/Oncology, Committee on Clinical Pharmacology and Pharmacogenomics, University of Chicago, IL 60637, USA.
Michael L
ML
Maitland
Richard L
RL
Schilsky
D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood; D001943:Breast Neoplasms / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000235:genetics / Q000628:therapy; D002986:Clinical Trials as Topic; D055088:Early Detection of Cancer; D005260:Female; D015894:Genome, Human; D006801:Humans; D008495:Medical Oncology / Q000639:trends*; D009369:Neoplasms / Q000188:drug therapy; D017239:Paclitaxel / Q000008:administration & dosage; D057285:Precision Medicine / Q000639:trends*; D012107:Research Design / Q000639:trends*; D018570:Risk Assessment; D012307:Risk Factors; D057170:Translational Research, Biomedical / Q000639:trends*; D000068878:Trastuzumab; D016896:Treatment Outcome
D061067:Antibodies, Monoclonal, Humanized; D014408:Biomarkers, Tumor; D000068878:Trastuzumab; D017239:Paclitaxel