Chapter 6. Purpose and Design of Clinical Trials

  1. John P Griffin BSc, PhD, MBBS, FRCP, FRCPath, FFPM1,
  2. John O'Grady MD, FRCP, FFPM, FBIRA, MRCPath2
  1. Roger A Yates

Published Online: 25 OCT 2007

DOI: 10.1002/9780470987391.ch6

The Textbook of Pharmaceutical Medicine, Fifth Edition

The Textbook of Pharmaceutical Medicine, Fifth Edition

How to Cite

Yates, R. A. (2007) Purpose and Design of Clinical Trials, in The Textbook of Pharmaceutical Medicine, Fifth Edition (eds J. P. Griffin and J. O'Grady), Blackwell Publishing Ltd, Oxford, UK. doi: 10.1002/9780470987391.ch6

Editor Information

  1. 1

    Director, Asklepieion Consultancy Ltd., Visiting Professor, University of Surrey Postgraduate Medical School, Former Director, Association of the British Pharmaceutical Industry, London, Formerly Professional Head of the Medicines Division, DHSS, London

  2. 2

    Visiting Professor of Clinical Pharmacology, University of London

Publication History

  1. Published Online: 25 OCT 2007
  2. Published Print: 15 DEC 2005

ISBN Information

Print ISBN: 9780727918406

Online ISBN: 9780470987391

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Keywords:

  • clinical trial;
  • harmaceutical medicine;
  • human pharmacology;
  • biomedical research;
  • placebo

Summary

This chapter contains sections titled:

  • Introduction

  • Basic Ethical Considerations

  • Compensation and Insurance

  • Pharmacogenetics

  • Studies in Special Groups

  • Clinical Trial Design

  • Sponsorship of Therapeutic Trials

  • Ownership of Clinical Trial Data

  • The Final Report

  • Regulatory Submissions

  • Publications

  • Conclusion