Essential Concepts in Clinical Research - 2nd Edition - ISBN: 9780702073946, 9780702073939

Essential Concepts in Clinical Research

2nd Edition

Randomised Controlled Trials and Observational Epidemiology

Authors: Kenneth Schulz David Grimes
Paperback ISBN: 9780702073946
eBook ISBN: 9780702073939
Imprint: Elsevier
Published Date: 24th September 2018
Page Count: 272

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This practical guide speaks to two audiences: those who read and those who conduct research. Clinicians are medical detectives by training. For each patient, they assemble clinical clues to establish causes of signs and symptoms. The task involves both clinical acumen and knowledge of medical research. This book helps guide clinicians through this detective work, by enabling them to make sense of research and to review medical literature critically. It will also be invaluable to researchers who conduct clinical research, particularly randomized controlled trials.

Building on previously published, peer-reviewed articles from The Lancet, this handbook is essential for busy clinicians and active researchers interested in research methods.

Key Features

  • Written by leaders in the field of clinical research who have published extensively with authorship of hundreds of articles in medical journals.
  • The authorship includes one of the three authors of the CONSORT guidelines for the reporting of randomized controlled trials.
  • The book presents the essential concepts to a wide array of topics including randomized control trials, descriptive studies, cohort studies, case-control studies, bias, and screening tests.
  • The book utilises a readable and humorous prose style, lightening what can be a difficult area for clinical readers.
  • Derived from decades of teaching clinical research in seminar settings the book will empower clinicians to make sense of, and critically appraise, current medical research and will enable researchers to enrich the quality of their work.

Table of Contents


1. An overview of clinical research: the lay of the land

 Observational studies

2. Descriptive studies: what they can and cannot do

3. Bias and causal associations in observational research

4. Cohort studies: marching towards outcomes

5. Case-control studies: research in reverse

6. Finding controls for case-control studies: compared to what?

7. Limitations of observational epidemiology

  Screening tests

8. Uses and abuses of screening tests

9. Refining clinical diagnosis with likelihood ratios

 Randomized controlled trials

10. Boosting participant recruitment in trials

11. Sample size calculations in randomized trials: mandatory and mystical

12. Generation of allocation sequences in randomized trials: chance not choice

13. Generation of allocation sequences in non-double-blinded randomized trials: guarding against guessing

14. Allocation concealment in randomized trials: defending against deciphering

15. Exclusions and losses in randomized trials: sample size slippages

16. Blinding in randomized trials: hiding who got what

17. Implementing treatment blinding in randomized trials

18. Surrogate endpoints and composite outcomes: shortcuts to unknown destinations

19. Multiplicity in randomized trials I: endpoints and treatments

20. Multiplicity in randomized trials II: subgroup and interim analyses

21. Conducting randomized trials as part of a prospective meta-analysis


22. Reporting studies in medical journals: CONSORT and other guidelines


No. of pages:
© Elsevier 2019
24th September 2018
Paperback ISBN:
eBook ISBN:

About the Authors

Kenneth Schulz

Affiliations and Expertise

Distinguished Scientist, FHI360, Durham, North Carolina, USA; Clinical Professor, Department of Obstetrics & Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, USA

David Grimes

Affiliations and Expertise

Clinical Professor, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, USA