Robert A. Parker, Nancy G. BermanCambridge University Press, 10/12/2016EAN 9780521549950, ISBN10: 0521549957Paperback, 440 pages, 24.9 x 17.5 x 2.3 cmLanguage: EnglishPlanning 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. Introduction1. Questions before starting on the details2. Ethics3. Informed consentPart II. Study Designs4. Overview of study designs5. Designs for interventional studies6. Cohort studies7. Case-control studies8. Cross-sectional studies9. Record reviews10. Selecting a designPart III. Core Concepts Applicable to All Study Designs11. Generalizability and validity12. Study population13. Getting and keeping participants14. Study data - how variables are used15. Study data - endpoints16. Predictor and confounding variables17. Bias18. Avoiding biasPart IV. Additional Concepts for Interventional Studies19. Describing your intervention20. Randomization - what and why21. Techniques for randomization22. Blinding23. Techniques needed for blinding intervention studies24. Compliance and adherencePart V. Additional Concepts for Observational Studies25. Defining populations for cohort studies26. Identifying participants for case-control studies27. Matching in nonrandomized studies28. Blinding in observational studiesPart VI. Practical Issues29. Acquiring high-quality data30. Data storage.
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