Chapter 8. Early Clinical Trials

  1. David Machin1,2,3 and
  2. Michael J. Campbell4

Published Online: 29 NOV 2005

DOI: 10.1002/0470012994.ch8

Design of Studies for Medical Research

Design of Studies for Medical Research

How to Cite

Machin, D. and Campbell, M. J. (2005) Early Clinical Trials, in Design of Studies for Medical Research, John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/0470012994.ch8

Author Information

  1. 1

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

  2. 2

    UK Children's Cancer Study Group, University of Leicester, UK

  3. 3

    Institute of General Practice and Primary Care, School of Health and Related Sciences, University of Sheffield, UK

  4. 4

    Medical Statistics Group, Institute of General Practice and Primary Care, School of Health and Related Sciences, University of Sheffield, UK

Publication History

  1. Published Online: 29 NOV 2005
  2. Published Print: 11 FEB 2005

ISBN Information

Print ISBN: 9780470844953

Online ISBN: 9780470012994

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Keywords:

  • early phase clinical trials;
  • pharmacokinetic studies;
  • ‘therapeutic window’;
  • maximum tolerated dose (MTD);
  • continual reassessment method (CRM);
  • Phase I and II trials;
  • assessing response;
  • two-stage design;
  • Simon – Optimal and Mini-max Designs;
  • Bryant and Day – Toxicity and Response Design

Summary

This chapter contains sections titled:

  • Introduction

  • Pharmacokinetic Studies

  • Phase I Trials

  • Phase II Trials

  • Practicalities

  • Technical Details