A Bayesian design for phase I cancer therapeutic vaccine trials

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Abstract

Phase I clinical trials are the first step in drug development to test a new drug or drug combination on humans. Typical designs of Phase I trials use toxicity as the primary endpoint and aim to find the maximum tolerable dosage. However, these designs are poorly applicable for the development of cancer therapeutic vaccines because the expected safety concerns for these vaccines are not as much as cytotoxic agents. The primary objectives of a cancer therapeutic vaccine phase I trial thus often include determining whether the vaccine shows biologic activity and the minimum dose necessary to achieve a full immune or even clinical response. In this paper, we propose a new Bayesian phase I trial design that allows simultaneous evaluation of safety and immunogenicity outcomes. We demonstrate the proposed clinical trial design by both a numeric study and a therapeutic human papillomavirus vaccine trial.

Original languageEnglish (US)
JournalStatistics in Medicine
DOIs
Publication statusAccepted/In press - Jan 1 2018

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Keywords

  • Bayesian
  • cancer therapeutic vaccine
  • clinical trial
  • HPV
  • Phase I

ASJC Scopus subject areas

  • Epidemiology
  • Statistics and Probability

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