Chapter 4. Design and Analysis of Phase II Trials

  1. Allan Hackshaw Deputy Director1,2

Published Online: 29 APR 2009

DOI: 10.1002/9781444311723.ch4

A Concise Guide to Clinical Trials

A Concise Guide to Clinical Trials

How to Cite

Hackshaw, A. (2009) Design and Analysis of Phase II Trials, in A Concise Guide to Clinical Trials, Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781444311723.ch4

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

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Keywords:

  • phase II trials – to examine potential effectiveness of intervention before embarking on a large, expensive phase III trial;
  • statistical significance level;
  • sample-size estimation;
  • standard deviation;
  • sufficient detail – characteristics of patients entered into the trial described;
  • efficacy, safety and feasibility – factors for conduct a larger, confirmatory trial

Summary

This chapter contains sections titled:

  • Purpose of phase II studies

  • Design

  • Choosing outcome measures

  • Sample size

  • Stopping early for toxicity

  • Statistical analysis

  • Interpreting and reporting phase II studies

  • Summary points

  • References