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Principles of Clinical Trial Design and Response Assessment

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Primary Central Nervous System Tumors

Part of the book series: Current Clinical Oncology ((CCO))

Abstract

This chapter is an overview of clinical trial design and conduct as it pertains to neuro-oncology. The basic principles involved in Phases 0, I, II, and III cancer clinical trials for both traditional cytotoxic agents and for the more recent molecularly targeted agents and cytostatic agents are discussed. Additionally, special challenges that must be considered in the design and implementation of brain tumor clinical trials are given closer examination including that of radiological response assessment.

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Author information

Authors and Affiliations

  1. Department of Neuro-Oncology, Brain Tumor Research Center, University of California, San Francisco, CA, USA

    Nicholas Butowski & Susan Chang MD

Authors
  1. Nicholas Butowski
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  2. Susan Chang MD
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Correspondence to Nicholas Butowski .

Editor information

Editors and Affiliations

  1. Dana-Farber Cancer Institute, Harvard Medical School, Binney St. 44, Boston, 02115, Massachusetts, USA

    Andrew D. Norden

  2. Departments of Surgery and Pediatrics, Duke University Medical Center, Durham, 27710, North Carolina, USA

    David A. Reardon

  3. Dana-Farber Cancer Institute, Harvard Medical School, Binney St. 44, Boston, 02115, Massachusetts, USA

    Patrick C. Y. Wen

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Butowski, N., Chang, S. (2011). Principles of Clinical Trial Design and Response Assessment. In: Norden, A., Reardon, D., Wen, P. (eds) Primary Central Nervous System Tumors. Current Clinical Oncology. Humana Press. https://doi.org/10.1007/978-1-60761-166-0_5

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  • DOI: https://doi.org/10.1007/978-1-60761-166-0_5

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  • Publisher Name: Humana Press

  • Print ISBN: 978-1-60761-165-3

  • Online ISBN: 978-1-60761-166-0

  • eBook Packages: MedicineMedicine (R0)

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