Chapter 10. A Primer on Clinical Trials and Critical Review of Clinical Trial Reports for the Clinician

  1. Peter P. Toth M.D., PH.D. Director of Preventive Cardiology Chief of Medicine Clinical Associate Professor1,2,3,4,
  2. Kevin C. Maki PH.D. President Chief Science Officer5

Published Online: 1 OCT 2008

DOI: 10.1002/9780470696873.ch10

Book Title

Practical Lipid Management: Concepts and Controversies

Practical Lipid Management: Concepts and Controversies

Additional Information

How to Cite

Toth, P. P. and Maki, K. C. (2008) A Primer on Clinical Trials and Critical Review of Clinical Trial Reports for the Clinician , in Practical Lipid Management: Concepts and Controversies, John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470696873.ch10

Author Information

  1. 1

    Sterling Rock Falls Clinic, Ltd., USA

  2. 2

    CGH Medical Center Sterling, Illinois, USA

  3. 3

    Departments of Family and Community Medicine, University of Illinois College of Medicine Peoria, Illinois, USA

  4. 4

    Southern Illinois University School of Medicine, Springfield, Illinois, USA

  5. 5

    Provident Clinical Research & Consulting, Inc., Glen Ellyn, Illinois and Bloomington, Indiana, USA

Publication History

  1. Published Online: 1 OCT 2008
  2. Published Print: 17 OCT 2008

ISBN Information

Print ISBN: 9780470056905

Online ISBN: 9780470696873

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CHAPTER TOOLS

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Keywords:

  • clinical trial primers;
  • randomized, controlled trial - ‘gold standard’ medical interventions evaluation;
  • study participant selection;
  • random treatment and allocation;
  • study subjects and blinding or masking;
  • chance, bias, and confounding;
  • efficacy versus effectiveness

Summary

This chapter contains sections titled:

  • Design Issues Affecting the Validity and Generalizability of Clinical Trial Results

  • Chance, Bias, and Confounding as Potential Explanations for Trial Results

  • Efficacy versus Effectiveness

  • Useful Questions to ask when Evaluating a Published Clinical Trial Report

  • Controversy: Should Lipid Drugs be Approved without Clinical Event Data?

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