Planning Clinical Research

Planning Clinical Research

Berman, Nancy; Parker, Robert A.

Cambridge University Press

10/2016

352

Dura

Inglês

9780521840637

15 a 20 dias

The authors draw on their many years working in clinical research to offer investigators practical guidance on the essential elements of study planning. Short chapters focus on specific clinical design aspects and a host of real-world examples illustrate key features and demonstrate what works and what does not.
Part I. Introduction: 1. Questions before starting on the details; 2. Ethics; 3. Informed consent; Part II. Study Designs: 4. Overview of study designs; 5. Designs for interventional studies; 6. Cohort studies; 7. Case-control studies; 8. Cross-sectional studies; 9. Record reviews; 10. Selecting a design; Part III. Core Concepts Applicable to All Study Designs: 11. Generalizability and validity; 12. Study population; 13. Getting and keeping participants; 14. Study data - how variables are used; 15. Study data - endpoints; 16. Predictor and confounding variables; 17. Bias; 18. Avoiding bias; Part IV. Additional Concepts for Interventional Studies: 19. Describing your intervention; 20. Randomization - what and why; 21. Techniques for randomization; 22. Blinding; 23. Techniques needed for blinding intervention studies; 24. Compliance and adherence; Part V. Additional Concepts for Observational Studies: 25. Defining populations for cohort studies; 26. Identifying participants for case-control studies; 27. Matching in nonrandomized studies; 28. Blinding in observational studies; Part VI. Practical Issues: 29. Acquiring high-quality data; 30. Data storage.
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