Clinical Trial Designs for Approval of New Anticancer Agents

  • Manpreet K. Chadha
  • Daniel D. Von Hoff
Part of the Cancer Drug Discovery and Development book series (CDD&D)


There is an imperative need for development of newer cancer therapeutics and their rapid availability for cancer patients. Better clinical trial designs may help cancer therapeutics become available for treatment sooner. This chapter focuses on our present knowledge about clinical trial design, discussions of successful trial designs, as well as proposals for novel strategies. An exhaustive review of methods used to select agents which are currently in use is included and followed by a summary table of all of the new agents considered by the Food and Drug Administration’s Oncologic Drug Advisory Committee, including the type of trial performed, approved versus disapproved, and the primary endpoint used for approval. Novel clinical trial design suggestions have been included. We hope the present effort helps readers understand various clinical trial designs and get them enthusiastic about exploring new designs.


Antineoplastic agents Drug therapy Clinical trial Drug approval Drugs Investigational Drug evaluation 



  This work was supported by the National Foundation for Cancer Research, Center for New Therapies Development (DVH), and by the Drug Development Scholar Program from The Scottsdale Healthcare Foundation (MKC) and Translational Drug Development Institute (TGen) (DVH).


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Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  1. 1.Clinical Trials at Virginia G Piper Cancer CenterScottsdaleUSA
  2. 2.TGen (Translational Genomics Research Institute)PhoenixUSA

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