UID:
almafu_9960118794202883
Format:
1 online resource (xxiii, 419 pages) :
,
digital, PDF file(s).
ISBN:
1-316-78915-2
,
1-316-79251-X
,
1-139-02471-X
Content:
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.
Note:
Title from publisher's bibliographic system (viewed on 05 Dec 2016).
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Cover -- Half-title -- Title page -- Copyright information -- Dedication -- Table of contents -- Preface -- Acknowledgments -- Part I Introduction -- 1 Questions before Starting on the Details -- 1.1 What Are the Broad Issues? -- 1.2 Question 1: Why Do You Want to Do Research? -- 1.3 Question 2: What Is Your Question? -- 1.4 Question 3: Why Does Answering This Question Matter? -- 1.5 Question 4: Why Are You the Person to Answer the Question? -- 1.6 Question 5: How Will You Know Whether You Have Answered Your Question? -- 1.7 Ethical Issues -- KEY POINTS -- References -- 2 Ethics -- 2.1 How Ethical Guidelines Developed -- 2.1.1 International Codes -- 2.1.2 The United States -- 2.2 Principles of Ethical Practice -- 2.2.1 Social and Clinical Value -- 2.2.2 Scientific Validity -- 2.2.3 Fair Subject Selection -- 2.2.4 Favorable Risk-Benefit Ratio -- 2.2.5 Independent Review -- 2.2.6 Informed Consent -- 2.2.7 Respect for Potential and Enrolled Subjects -- 2.3 The Institutional Review Board (IRB) -- 2.4 The Data Safety and Monitoring Board (DSMB) -- 2.5 Resources for Further Reading -- KEY POINTS -- 3 Informed Consent -- 3.1 The Consent Process -- 3.1.1 The Consent Document -- 3.1.2 The Consent Interview -- 3.2 The Authorization Form for Protecting Data -- 3.3 Coercion and Undue Influence -- 3.4 Special Populations -- 3.4.1 Children -- 3.4.2 Persons Unable to Understand and Agree to the Study -- 3.4.3 Speakers of Other Languages -- 3.4.4 Pregnant Women, Fetuses or Neonates -- 3.4.5 Prisoners -- 3.5 Use and Retention of Tissue Samples -- 3.6 Situations When Consent Is Not Required or May Be Postponed -- 3.7 Ethical Issues -- KEY POINTS -- Part II Study Designs -- 4 Overview of Study Designs -- 4.1 Interventional Designs -- 4.2 Designs for Observational Studies -- 4.3 Clinical Trials.
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4.4 Different Questions May Represent Different Designs in the Same Study -- 4.5 How You Frame the Question Affects the Types of Studies Possible -- 4.6 Advantages of Interventional Studies -- 4.7 Difficulties of Interventional Studies -- 4.8 Ethical Issues -- KEY POINTS -- 5 Designs for Interventional Studies -- 5.1 Summary of Interventional Designs -- 5.2 The Question Being Studied -- 5.3 Studies in Which All Participants Receive the Intervention -- 5.3.1 Single Group of Participants -- 5.3.2 More Than One Group of Participants -- 5.4 Studies in Which Some Participants Receive the Intervention and Some Do Not: Parallel Group Studies -- 5.5 Studies in Which All Participants Are Studied with and without the Intervention -- 5.5.1 Comparison within a Single Participant with Intervention in Random Order (Crossover Study) -- 5.5.2 Comparison within a Single Participant with Intervention in Fixed Order (Pre-Post Study) -- 5.6 Ethical Issues -- KEY POINTS -- 6 Cohort Studies -- 6.1 Basic Designs -- 6.2 Advantages of Cohort Studies Compared to Interventional Studies -- 6.3 Disadvantages of Cohort Studies Compared to Interventional Studies -- 6.4 Prospective versus Retrospective Cohort Studies -- 6.5 Ethical Issues -- KEY POINTS -- 7 Case-Control Studies -- 7.1 Basic Design -- 7.2 Selecting Participants -- 7.3 Matching -- 7.4. Nested Case-Control Studies -- 7.5 Advantages and Disadvantages of Case-Control Studies -- 7.6 Ethical Issues -- KEY POINTS -- 8 Cross-Sectional Studies -- 8.1 Fundamental Features -- 8.2 Examples of Cross-Sectional Studies -- 8.3 Some Common Problems in Cross-Sectional Studies -- 8.4 Ethical Issues -- KEY POINTS -- 9 Record Reviews -- 9.1 Data Availability and Quality -- 9.1.1 Data Availability -- 9.1.2 Data Quality -- 9.1.3 What Can Be Done about Data Problems? -- 9.2 Examples of Record Reviews -- 9.3 Ethical Issues -- KEY POINTS.
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10 Selecting a Design -- 10.1 A Range of Designs -- 10.2 Interventional or Observational Study? -- 10.2.1 Is an Interventional Study Ethical? -- 10.2.2 Is an Interventional Study Practical? -- 10.3 Selecting an Interventional Study Design -- 10.3.1 Randomized or Non-Randomized Study? -- 10.3.2 Parallel Group or Crossover Study? -- 10.4 Observational Studies -- 10.4.1 Case-Control or Cohort Study? -- 10.4.2 Cohort Study: Retrospective or Prospective? -- 10.5 Example of Developing a Design -- 10.6 Ethical Issues -- KEY POINTS -- Part III Core Concepts Applicable to All Study Designs -- 11 Generalizability and Validity -- 11.1 The Population -- 11.2 Study Methods -- 11.2.1 Treatment and Treatment Monitoring -- 11.2.2 Assessment Methods -- 11.3 Validity -- 11.4 Ethical Issues -- KEY POINTS -- 12 Study Population -- 12.1 The Target Population and the Study Pool -- 12.2 The Eligible Group -- 12.3 The Study Group -- 12.4 Ethical Issues -- KEY POINTS -- 13 Getting and Keeping Participants -- 13.1 Recruiting the Right Number of Participants -- 13.2 Recruitment and Retention Is Part of Planning -- 13.3 Locating and Recruiting Participants -- 13.4 Retention and Adherence -- 13.5 Use of the Internet -- 13.6 Ethical Issues -- KEY POINTS -- 14 Study Data: How Variables Are Used -- 14.1 Types of Variables -- 14.2 Role of Variables in an Interventional Study -- 14.3 Role of Variables in Observational Studies -- 14.4 Measuring Variables -- 14.5 Recoding Data -- 14.6 Storing Data -- 14.7 Ethical Issues -- KEY POINTS -- 15 Study Data: Endpoints -- 15.1 Defining the Outcome Variables -- 15.2 Derived Outcomes -- 15.3 Time-Related Outcomes -- 15.4 Ethical Issues -- KEY POINTS -- 16 Study Data: Predictor and Confounding Variables -- 16.1 Predictor Variables -- 16.2 Confounding Variables -- 16.3 Predictors versus Confounders -- 16.4 Ethical Issues -- KEY POINTS -- 17 Bias.
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17.1 Common Sources of Bias -- 17.1.1 Prognostic Bias -- 17.1.2 Selection Bias -- 17.1.3 Participant Bias -- 17.1.4 Recall Bias -- 17.1.5 Bias Due to the Learning Effect -- 17.1.6 Care Provider Bias -- 17.1.7 Assessor (Rater) Bias -- 17.1.8 Laboratory Bias -- 17.1.9 Analysis Bias -- 17.1.10 Interpretation Bias -- 17.1.11 Publication Bias -- 17.2 Non-Differential Bias -- 17.3 Ethical Issues -- KEY POINTS -- 18 Avoiding Bias -- 18.1 Selection of Study Population -- 18.2 Randomization -- 18.3 Blinding -- 18.4 Assessment Methods and Training -- 18.5 Data Monitoring during the Study -- 18.6 Ethical Issues -- KEY POINTS -- Part IV Additional Concepts for Interventional Studies -- 19 Describing the Intervention -- 19.1 Problems in Describing an Intervention -- 19.2 Determining the Control Intervention -- 19.3 Describing the Control Intervention -- 19.4 Ethical Issues -- KEY POINTS -- 20 Randomization: What and Why -- 20.1 What Is Randomization? -- 20.2 Why Randomize? -- 20.3 Why Randomize Individuals? -- 20.4 Ethical Issues -- KEY POINTS -- 21 Techniques for Randomization -- 21.1 Requirements for a Valid Randomized Study -- 21.2 Creating a Randomization Schedule -- 21.3 Adding Special Features to the Randomization Schedule -- 21.3.1 Stratification -- 21.3.2 Blocking -- 21.3.3 Benefits and Pitfalls of Stratification and Blocking -- 21.4 Unbalanced Randomization -- 21.5 Ethical Issues -- KEY POINTS -- 22 Blinding in Interventional Studies -- 22.1 Why Blinding Is Used -- 22.2 The Hierarchy of Blinding -- 22.2.1 Double-Blind Studies -- 22.2.2 Complete Blinding -- 22.2.3 Single-Blind Studies -- 22.2.4 Open-Label Studies -- 22.2.5 Multiple Levels of Blinding -- 22.3 Monitoring Safety and Breaking the Blind -- 22.4 When the Blind Is Broken -- 22.5 Ethical Issues -- KEY POINTS -- 23 Techniques to Blind Interventional Studies -- 23.1 Masking the Intervention.
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23.1.1 Masking a Pharmaceutical Intervention -- 23.1.2 Maintaining the Mask When Dosage Levels Change -- 23.1.3 Masking for Non-Pharmaceutical Intervention -- 23.1.4 Masking Laboratory Staff -- 23.1.5 Masking Data Management Staff -- 23.2 Providing the Intervention in Blinded Studies -- 23.2.1 Treatment Allocation by the Manufacturer -- 23.2.2 The Institutional Pharmacy -- 23.2.3 Allocation by a Member of the Study Team -- 23.2.4 Keeping the Randomization Confidential -- 23.3 Common Problems Maintaining Masking -- 23.3.1 Side Effects -- 23.3.2 Efficacy -- 23.3.3 Leaks and Guesses -- 23.4 Ethical Issues -- KEY POINTS -- 24 Adherence and Compliance -- 24.1 Efficacy versus Effectiveness -- 24.2 Adherence: How Is It Assessed? -- 24.3 Overall Measures to Improve Adherence -- 24.4 Measures to Improve Retention in the Study -- 24.5 Ethical Issues -- KEY POINTS -- Part V Additional Concepts for Observational Studies -- 25 Defining Populations for Cohort Studies -- 25.1 Data Availability -- 25.1.1 Data Sources -- 25.1.2 Stratified Sampling -- 25.2 Quality of Information -- 25.3 Study Time Line -- 25.4 Multiple Cohort Studies -- 25.5 Ethical Issues -- KEY POINTS -- 26 Participants in Case-Control Studies -- 26.1 Identifying Cases and Controls -- 26.1.1 General Considerations -- 26.1.2 Identifying Cases -- 26.1.3 Identifying Controls -- 26.2 Inclusion and Exclusion Criteria for Controls -- 26.3 Special Situations -- 26.3.1 Multiple Control Groups -- 26.3.2 Case-Control Studies within Cohort Studies -- 26.3.3 Historical Controls -- 26.4 Should the Sizes of the Groups Be the Same? -- 26.5 Ethical Issues -- KEY POINTS -- 27 Matching in Observational Studies -- 27.1 Why Match? -- 27.2 Who Are You Matching? -- 27.3 When Is Matching Done? -- 27.4 Individual Matching -- 27.4.1 Defining Matching Criteria -- 27.4.2 Choosing between Eligible Controls.
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27.5 Frequency Matching.
Additional Edition:
ISBN 0-521-54995-7
Additional Edition:
ISBN 0-521-84063-5
Language:
English
URL:
https://doi.org/10.1017/CBO9781139024716
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