Essential Concepts in Clinical Research. Randomised Controlled Trials and Observational Epidemiology (Print and Online)

Introduction

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

Publishing

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

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.

New to this Edition

The updated new edition includes six new chapters:

• Surrogate endpoints
• Limitations of observational epidemiology
• Participant recruitment
• Practicalities of double-blinding
• Randomized trials in the context of a prospective meta-analysis
• Reporting studies in medical journals: CONSORT

Author Information
By Kenneth Schulz, PhD, MBA, Distinguished Scientist, Quantitative Sciences, FHI360, Durham, North Carolina, USA and David A. Grimes, MD, Clinical Professor, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, USA