Clinical trials in the era of personalized oncology


  • Michael L. Maitland MD, PhD,

    1. Assistant Professor of Medicine, Section of Hematology/Oncology, Associate Director, Committee on Clinical Pharmacology and Pharmacogenomics, University of Chicago, Chicago, IL
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  • Richard L. Schilsky MD

    Corresponding author
    1. Professor of Medicine and Chief, Section of Hematology/Oncology, Deputy Director, Comprehensive Cancer Center, University of Chicago, Chicago, IL
    • Section of Hematology/Oncology, Comprehensive Cancer Center, University of Chicago, MC 2115, 5841 S Maryland Ave, Chicago, IL 60637
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  • DISCLOSURES: Dr. Maitland was supported by K23CA124802.


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. CA Cancer J Clin 2011. © 2011 American Cancer Society.