Chapter 16. Phase II Trials

  1. David Machin1,2,3,
  2. Michael J. Campbell3,
  3. Say Beng Tan4,5 and
  4. Sze Huey Tan2

Published Online: 30 JAN 2009

DOI: 10.1002/9781444300710.ch16

Sample Size Tables for Clinical Studies, Third Edition

Sample Size Tables for Clinical Studies, Third Edition

How to Cite

Machin, D., Campbell, M. J., Tan, S. B. and Tan, S. H. (2008) Phase II Trials, in Sample Size Tables for Clinical Studies, Third Edition, Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781444300710.ch16

Author Information

  1. 1

    Children's Cancer and Leukaemia Group, University of Leicester, UK

  2. 2

    Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre, Singapore

  3. 3

    Medical Statistics Unit, School of Health and Related Sciences, University of Sheffield, UK

  4. 4

    Singapore Clinical Research Institute, Singapore

  5. 5

    Duke–NUS Graduate Medical School, Singapore

Publication History

  1. Published Online: 30 JAN 2009
  2. Published Print: 21 NOV 2008

ISBN Information

Print ISBN: 9781405146500

Online ISBN: 9781444300710



  • two-stage designs for Phase II trials;
  • single-stage procedure;
  • Fleming–A'Hern;
  • Simon–Optimal and Simon–Minimax;
  • Bayesian two-stage designs;
  • dual threshold design (DTD) identical to STD;
  • survival time and survival proportion endpoints;
  • expected duration of accrual (EDA) design;
  • response and toxicity endpoints;
  • Simon–Wittes–Ellenberg design


This chapter contains sections titled:

  • Introduction

  • Theory and formulae

  • Bibliography

  • Examples and use of the tables

  • References