4. Phase I Trial Design

  1. Guosheng Yin

Published Online: 9 JAN 2012

DOI: 10.1002/9781118183335.ch4

Clinical Trial Design: Bayesian and Frequentist Adaptive Methods

Clinical Trial Design: Bayesian and Frequentist Adaptive Methods

How to Cite

Yin, G. (2011) Phase I Trial Design, in Clinical Trial Design: Bayesian and Frequentist Adaptive Methods, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9781118183335.ch4

Publication History

  1. Published Online: 9 JAN 2012
  2. Published Print: 19 DEC 2011

ISBN Information

Print ISBN: 9780470581711

Online ISBN: 9781118183335

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Keywords:

  • Bayesian model selection (BMS);
  • clinical trial design;
  • continual reassessment method (CRM);
  • dose-limiting toxicities (DLTs);
  • escalation with overdose control (EWOC);
  • maximum tolerated dose (MTD)

Summary

The aims of a typical phase I oncology trial are to determine the maximum tolerated dose (MTD), assess the safety and tolerability, and investigate pharmacokinetics and pharmacodynamics of a new drug. The dose-limiting toxicities (DLTs) refer to the drug-induced toxicities up to a certain level of severity so that no more of the treatment can be given to patients. In particular, the continual reassessment method (CRM) links the true toxicity probability at each dose with the prespecified toxicity probability through a single-parameter model. In contrast to model averaging, Bayesian model selection (BMS) finds the best fitting model according to a suitable criterion among all the candidate models. The Escalation with overdose control (EWOC) design directly controls the toxicity percentage in a trial such that patients are protected from over-toxic doses.

Controlled Vocabulary Terms

Bayesian network