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The Design of Studies for Medical Research

The Design of Studies for Medical Research

David Machin, Michael J. Campbell

ISBN: 978-0-470-01298-7

May 2005

286 pages



The same careful rigour imposed on the design of phase III randomised controlled trials is not always applied to medical research in other areas such as trials conducted at earlier stages of drug development. 

With the emphasis that is now placed on evidence-based medicine, such care and rigour will inevitably impact on these areas with increasing attention turned to the quality of design. 

This title describes what principles can be used to structure research effectively allowing for the required degree of accuracy.

Written by two best selling authors, this book includes many examples from medical literature and will be of great value to all groups conducting studies at the interface of clinical and laboratory research.


Chapter 1. What is Evidence.

Chapter 2. Measurement, Forms and Questionnaires.

Chapter 3. Principles of Study Size Calculation.

Chapter 4. Randomisation.

Chapter 5. Cross-sectional Longitudinal Studies.

Chapter 6. Surveys, Cohort and Case-Control Studies.

Chapter 7. Clinical Trails - General Issues.

Chapter 8. Early Clinical Trials.

Chapter 9. Phase III Trials.

Chapter 10. Diagnosis.

Chapter 11. Prognostic Factor Studies.




"…a thorough but concise introduction to study design and data analysis." (E-STREAMS, June 2006)

"…a very good attempt to discuss various aspects of clinical research…" (Journal of Biopharmaceutical Statistics, July/August 2006)

"This is a well researched, well written, thoughtful, and…easy to read primer…a valuable addition to books for research physicians, medical students, and others…" (Doody's Health Services)

"…this book is surprisingly refreshing…could be used in any number of situations with equality utility…" (Canadian Journal of Medical Laboratory Science, 2005)

  • Includes many examples from medical literature
  • Each chapter begins with a short summary
  • Written by two bestselling authors