Planning Clinical Research

Planning clinical research requires many decisions. The authors of this book explain key decisions with examples showing what works and what does not.

Robert A. Parker (Author), Nancy G. Berman (Author)

9780521549950, Cambridge University Press

Paperback, published 12 October 2016

440 pages
24.8 x 17.4 x 2.3 cm, 0.78 kg

Planning a clinical study is much more than determining the basic study design. Who will you be studying? How do you plan to recruit your study subjects? How do you plan to retain them in the study? What data do you plan to collect? How will you obtain this data? How will you minimize bias? All these decisions must be consistent with the ethical considerations of studying people. This book teaches how to choose the best design for your question. Drawing on their many years working in clinical research, Nancy G. Berman and Robert A. Parker guide readers through the essential elements of study planning to help get them started. The authors offer numerous examples to illustrate the key decisions needed, describing what works, what does not work, and why. Written specifically for junior investigators beginning their research careers, this guide will also be useful to senior investigators needing to review specific topics.

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.

Subject Areas: Probability & statistics [PBT], Epidemiology & medical statistics [MBNS]