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Recent developments in the design of phase II clinical trials

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Recent Advances in Clinical Trial Design and Analysis

Part of the book series: Cancer Treatment and Research ((CTAR,volume 75))

Abstract

Clinical trials of new medical treatments may be classified into three successive phases. Phase I trials typically are small pilot studies to determine the therapeutic dose of a drug, biological agent, radiation schedule, or a combination of these regimens (cf. [1]). In cancer therapeutics, the underlying idea is that a higher dose of the therapeutic agent kills more cancer cells but also is more likely to harm and possibly kill the patient. Consequently, toxicity is the usual criterion for determining a maximum tolerable dose (MTD), and most phase I cancer trials involve very small groups of patients, usually three to six patients per dose, with each successive group receiving a higher dose until it is likely that the MTD has been reached. A more refined approach that continually updates an estimate of the probability of toxicity has also been proposed by O’Quigley, Pepe and Fisher [2].

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Authors
  1. Peter F. Thall
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  2. Richard M. Simon
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Editor information

Editors and Affiliations

  1. Department of Biomathematics, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Boulevard, Box 237, Houston, Texas, 77030, USA

    Peter F. Thall Ph.D.

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© 1995 Springer Science+Business Media New York

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Thall, P.F., Simon, R.M. (1995). Recent developments in the design of phase II clinical trials. In: Thall, P.F. (eds) Recent Advances in Clinical Trial Design and Analysis. Cancer Treatment and Research, vol 75. Springer, Boston, MA. https://doi.org/10.1007/978-1-4615-2009-2_3

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  • DOI: https://doi.org/10.1007/978-1-4615-2009-2_3

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-1-4613-5830-5

  • Online ISBN: 978-1-4615-2009-2

  • eBook Packages: Springer Book Archive

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