Planning Clinical Research

Robert A. Parker; Nancy G. Berman

doi:10.1017/CBO9781139024716

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Robert A. Parker, Harvard Medical School, Massachusetts, Nancy G. Berman, Harbor-UCLA Medical Center

Publisher:: Cambridge University Press
Online publication date:: November 2016
Print publication year:: 2016
Online ISBN:: 9781139024716
DOI:: https://doi.org/10.1017/CBO9781139024716

Subjects:: Statistics for Life Sciences, Medicine and Health, Epidemiology Public Health and Medical Statistics, Medicine, Statistics and Probability

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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.

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Planning Clinical Research

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Contents

Planning Clinical Research
pp i-ii

Planning Clinical Research - Title page
pp iii-iii

Copyright page
pp iv-iv

Dedication
pp v-vi

Contents
pp vii-xviii

Preface
pp xix-xxii

Acknowledgements
pp xxiii-xxiv

Part I - Introduction
pp 1-44

1 - Questions before Starting on the Details
pp 3-13

2 - Ethics
pp 14-27

3 - Informed Consent
pp 28-44

Part II - Study Designs
pp 45-134

4 - Overview of Study Designs
pp 47-61

5 - Designs for Interventional Studies
pp 62-81

6 - Cohort Studies
pp 82-94

7 - Case-Control Studies
pp 95-103

8 - Cross-Sectional Studies
pp 104-110

9 - Record Reviews
pp 111-118

10 - Selecting a Design
pp 119-134

Part III - Core Concepts Applicable to All Study Designs
pp 135-226

11 - Generalizability and Validity
pp 137-146

12 - Study Population
pp 147-160

13 - Getting and Keeping Participants
pp 161-174

14 - Study Data: How Variables Are Used
pp 175-186

15 - Study Data: Endpoints
pp 187-195

16 - Study Data: Predictor and Confounding Variables
pp 196-202

17 - Bias
pp 203-216

18 - Avoiding Bias
pp 217-226

Part IV - Additional Concepts for Interventional Studies
pp 227-294

19 - Describing the Intervention
pp 229-236

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