Selected as a Doody's Core Title for 2022!


For more than 30 years, Designing Clinical Research has set the standard as the most practical, authoritative guide for physicians, nurses, pharmacists, and other practitioners involved in all forms of clinical and public health research. Using a reader-friendly writing style, Drs. Warren S. Browner, Thomas B. Newman, Steven R. Cummings, Deborah G. Grady, Alison J. Huang, Alka M. Kanaya, and Mark J. Pletcher, all of the University of California, San Francisco, provide up-to-date, commonsense approaches to the challenging judgments involved in designing, funding, and implementing a study. This state-of-the-art fifth edition features new figures, tables, and design, as well as new editors, new content, and extensively updated references to keep you current.
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Covers clinical research in its many forms, including clinical trials, observational studies, translational science, and patient-oriented research.

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Presents epidemiologic terms and principles and advanced conceptual material in a practical and reader-friendly manner.

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Discusses key changes in the field, including confounding and directed acyclic graphs, surrogate outcomes and biomarkers, instrumental variables and Mendelian randomization, regression discontinuity designs, alternative data sources, AI and machine learning, pilot studies, as well as an update on P values and Bayesian analysis..

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Covers modifications of classic randomized trials, such as pre/post, interrupted time series, difference-in-differences, stepped wedge and cluster randomized designs, as well as randomized trials in health systems.

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Adds new chapters on qualitative approaches to clinical research and on community-engaged research


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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