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ASCO Educational Book; 2009
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Conducting Clinical Trials for Patients Who Are Frail or Elderly

Martine Extermann, MD, and Hyman B. Muss, MD

From the Moffitt Cancer Center, University of South Florida, Tampa, FL; and Hematology Oncology Unit, Vermont Cancer Center, University of Vermont, Burlington, VT

Authors’ disclosures of potential conflicts of interest are found at the end of this article.

Address reprint requests to Dr. Martine Extermann, Senior Adult Oncology Program, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612; e-mail: martine.extermann{at}moffitt.org

Overview: Patients who are older and frail are underrepresented in clinical trials. However, pioneering experience is being acquired with appropriate trial designs and recruitment strategies. This chapter will discuss current definitions of vulnerable and frail patients, design techniques for studies targeting this population, and strategies to enhance recruitment.