Description:

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.

• Covers clinical research in its many forms, including clinical trials, observational studies, translational science, and patient-oriented research.

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

• 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..

• 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.

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

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- Table of Contents -

SECTION I. Basic Ingredients

1. Getting Started: The Anatomy and Physiology of Clinical Research

2. Conceiving the Research Question and Developing the Study Plan

3. Choosing the Study Participants: Specification, Sampling, and Recruitment

4. Planning the Measurements: Precision Accuracy, and Validity

5. Getting Ready to Estimate Sample Size: Hypotheses and Underlying Principles

6. Estimating Sample Size: Applications and Examples

7. Addressing Ethical Issues

SECTION II. Study Designs

8. Designing Cross-Sectional and Cohort Studies

9. Designing Case-Control Studies

10. Estimating Causal Effects Using Observational Studies

11. Designing Randomized Blinded Trials

12. Alternate Interventional Study Designs

13. Designing Studies of Medical Tests

14. Qualitative Approaches in Clinical Research

SECTION III. Approaches and Implementation

15. Community-Engaged Research

16. Research Using Existing Data or Specimens

17. Designing, Selecting, and Administering Self-Reported Measures

18. Study Implementation and Quality Control

19. Data Management

20. Writing a Proposal for Funding a Research Study

Answers to the Exercises at the Ends of Chapters

Glossary 

Index