Chapter 3. Design and Analysis of Phase I Trials

  1. Allan Hackshaw Deputy Director1,2

Published Online: 29 APR 2009

DOI: 10.1002/9781444311723.ch3

A Concise Guide to Clinical Trials

A Concise Guide to Clinical Trials

How to Cite

Hackshaw, A. (2009) Design and Analysis of Phase I Trials, in A Concise Guide to Clinical Trials, Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781444311723.ch3

Author Information

  1. 1

    Cancer Research, UK

  2. 2

    UCL Cancer Trials Centre, UK

Publication History

  1. Published Online: 29 APR 2009
  2. Published Print: 10 APR 2009

ISBN Information

Print ISBN: 9781405167741

Online ISBN: 9781444311723

SEARCH

Keywords:

  • phase I trials – to examine biological and pharmacological actions of a new treatment;
  • traditional anti-cancer drugs;
  • dose-limiting toxicity (DLT);
  • a Fibonacci sequence;
  • pharmacodynamics: physical or biological measures that show the effect of new drug on the body;
  • Cmax – highest concentration level

Summary

This chapter contains sections titled:

  • Design

  • Non-toxicity endpoints

  • Statistical analysis and reporting the trial results

  • Summary points

  • References