Designing Clinical Research, 3rd Edition – Instant PDF Download
By Stephen B. Hulley, Steven R. Cummings, Warren S. Browner, Deborah G. Grady and Thomas B. Newman.
Designing Clinical Research (3rd Edition) is a comprehensive and practical guide for health professionals and researchers looking to understand and implement effective clinical research studies. The book walks readers through every stage of study design — from formulating the research question to selecting subjects, planning measurements, choosing a study design, estimating sample size, managing data, addressing ethics, and writing successful proposals. It combines theory with hands-on strategies and real-world examples, making complex research concepts accessible, especially for early-career investigators.
The third edition includes updates on emerging methodologies such as case-crossover designs, adaptive trials, Mendelian randomization, and use of big data. It also places a strong emphasis on internal and external validity, ethical conduct, and quality control in research implementation.
1. Getting Started: The Anatomy and Physiology of Clinical Research
2. Conceiving the Research Question
3. Choosing the Study Subjects: Specification, Sampling, and Recruitment
4. Planning the Measurements: Precision and Accuracy
5. Getting Ready to Estimate Sample Size: Hypotheses and Underlying Principles
6. Estimating Sample Size and Power: Applications and Examples
7. Designing a Cohort Study
8. Designing Cross-Sectional and Case–Control Studies
9. Enhancing Causal Inference in Observational Studies
10. Designing a Randomized Blinded Trial
11. Alternative Trial Designs and Implementation Issues
12. Designing Studies of Medical Tests
13. Utilizing Existing Databases
14. Addressing Ethical Issues
15. Designing Questionnaires and Interviews
16. Data Management
17. Implementing the Study and Quality Control
18. Community and International Studies
19. Writing and Funding a Research Proposal
20. Exercises
21. Answers
22. Subject Index
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