Designing Clinical Research 4E

Designing Clinical Research has been extensively revised and continues to set the standard as a practical guide for doctors, nurses, pharmacists, and other health professionals involved in all forms of clinical, translational, and public health research. It presents advanced epidemiologic concepts in a reader-friendly way, and suggests common sense approaches to the challenging judgments involved in designing, funding, and implementing.

New to this edition:
Expanded and updated content in every chapter, with new material on: • non-inferiority trials for comparative effectiveness research • incidence-density case-control studies • confounding and effect modification • diagnostic test studies to inform prediction rules • ethical aspects of whole genome sequencing • automated data management approaches • new NIH grant-writing requirements
Color format, and Electronic access, powered by Inkling™ as a free companion to the text • viewable through your browser or as a download to tablet or smartphone • the complete text with optimized navigation • note-sharing, highlighting and bookmarking capability • cross-linking of references and content • rapid search options linked to the new glossary

4 -color design
New approaches to sample size estimation, keeping it simple while covering more design options
Examples and ideas on what's new in clinical research
Exercises that highlight major clinical research issues
Treatment of clinical trial design and implementation

Section I
Basic Ingredients
 
1 Getting Started: The Anatomy and Physiology of Clinical Research
Stephen B. Hulley, Thomas B. Newman, and Steven R. Cummings

 2 Conceiving the Research Question and Developing the Study Plan
Steven R. Cummings, Warren S. Browner, and Stephen B. Hulley

 3 Choosing the Study Subjects: Specification, Sampling, and Recruitment
Stephen B. Hulley, Thomas B. Newman, and Steven R. Cummings

 4 Planning the Measurements: Precision, Accuracy and Validity
Stephen B. Hulley, Thomas B. Newman and Steven R. Cummings
 
5 Getting Ready to Estimate Sample Size: Hypotheses and Underlying Principles
Warren S. Browner, Thomas B. Newman, and Stephen B. Hulley 

6 Estimating Sample Size and Power: Applications and Examples
Warren S. Browner, Thomas B. Newman, and Stephen B. Hulley

Section II
Study Designs
 
7 Designing Cross-Sectional and Cohort Studies
Stephen B. Hulley, Steven R. Cummings, and Thomas B. Newman 

8 Designing Case–Control Studies
Thomas B.Newman, Warren S.Browner, Steven R.Cummings, and Stephen B.Hulley
 
9 Enhancing Causal Inference in Observational Studies
Thomas B. Newman, Warren S. Browner, and Stephen B. Hulley 

10 Designing a Randomized Blinded Trial
Steven R. Cummings, Deborah Grady, and Stephen B. Hulley 

11 Alternative Trial Designs and Implementation Issues
Deborah Grady, Steven R. Cummings, and Stephen B. Hulley 

12 Designing Studies of Medical Tests
Thomas B.Newman, Warren S.Browner, Steven R.Cummings, and Stephen B. Hulley 

13 Research Using Existing Data
Deborah Grady, Steven R. Cummings and Stephen B. Hulley

Section III
Implementation
 
14 Addressing Ethical Issues
Bernard Lo and Deborah Grady 

15 Designing Questionnaires, Interviews and Online Surveys
Steven R. Cummings, Michael A. Kohn, and Stephen B. Hulley 

16 Data Management
Michael A. Kohn, Thomas B. Newman, and Stephen B. Hulley 

17 Implementing the Study and Quality Control
Deborah Grady and Stephen B. Hulley 

18 Community and International Studies
Norman Hearst and Thomas Novotny 

19 Writing and Funding a Research Proposal

Steven R. Cummings and Stephen B. Hulley


Exercises

Answers to Exercises

Glossary