Planning clinical research:
Saved in:
| Main Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York, NY, USA
Cambridge University Press
[2016]
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| Subjects: | |
| Online Access: | Inhaltsverzeichnis Klappentext |
| Item Description: | Includes bibliographical references and index |
| ISBN: | 9780521840637 9780521549950 |
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Contents
Preface
Acknowledgments
PART I INTRODUCTION
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
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
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Contents
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
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
Overview of Study Designs
4.1 Interventional Designs
4.2 Designs for Observational Studies
4.3 Clinical Trials
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
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Contents
Designs for Interventional Studies
5.1 Summary of Interventional Designs
5.2 The Question Being Studied
5.3 Studies in Which AU 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: ParaUel 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
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
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
Cross-Sectional Studies
8.1 Fundamental Features
8.2 Examples of Cross-Sectional Studies
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Contents
8.3 Some Common Problems in Cross-Sectional Studies 108
8.4 Ethical Issues 109
Key Points 110
9. Record Reviews 111
9.1 Data Availability and Quality 111
9.1.1 Data Availability 111
9.1.2 Data Quality 113
9.1.3 What Can Be Done about Data Problems? 114
9.2 Examples of Record Reviews 115
9.3 Ethical Issues 118
Key Points 118
10. Selecting a Design 119
10.1 A Range of Designs 119
10.2 Interventional or Observational Study? 120
10.2.1 Is an Interventional Study Ethical? 120
10.2.2 Is an Interventional Study Practical? 123
10.3 Selecting an Interventional Study Design 124
10.3.1 Randomized or Non-Randomized Study? 124
10.3.2 Parallel Group or Crossover Study? 126
10.4 Observational Studies 127
10.4.1 Case-Control or Cohort Study? 127
10.4.2 Cohort Study: Retrospective or Prospective? 129
10.5 Example of Developing a Design 130
10.6 Ethical Issues 132
Key Points 133
PART III CORE CONCEPTS APPLICABLE
TO ALL STUDY DESIGNS 135
11. Generalizabilty and Validity 137
11.1 The Population 137
11.2 Study Methods 140
11.2.1 Treatment and Treatment Monitoring 140
11.2.2 Assessment Methods 142
1L3 Validity 143
11.4 Ethical Issues 144
Key Points 145
xi Contents
12. Study Population 147
12.1 The Target Population and the Study Pool 147
12.2 The Eligible Group 148
12.3 The Study Group 157
12.4 Ethical Issues 158
Key Points 159
13. Getting and Keeping Participants 161
13.1 Recruiting the Right Number of Participants 161
13.2 Recruitment and Retention Is Part of Planning 163
13.3 Locating and Recruiting Participants 164
13.4 Retention and Adherence 168
13.5 Use of the Internet 171
13.6 Ethical Issues 172
Key Points 174
14. Study Data: How Variables Are Used 175
14.1 Types of Variables 175
14.2 Role of Variables in an Interventional Study 176
14.3 Role of Variables in Observational Studies 181
14.4 Measuring Variables 183
14.5 Recoding Data 184
14.6 Storing Data 184
14.7 Ethical Issues 185
Key Points 186
15. Study Data: Endpoints 187
15.1 Defining the Outcome Variables 187
15.2 Derived Outcomes 190
15.3 Time-Related Outcomes 192
15.4 Ethical Issues 194
Key Points 195
16. Study Data: Predictor and Confounding Variables 196
16.1 Predictor Variables 196
16.2 Confounding Variables 198
16.3 Predictors versus Confounders 199
16.4 Ethical Issues 200
Key Points 201
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Contents
Bias
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
Non-Differential Bias
Ethical Issues
Key Points
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
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
Contents
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20. Randomization: What and Why 237
20.1 What Is Randomization? 237
20.2 Why Randomize? 240
20.3 Why Randomize Individuals? 242
20.4 Ethical Issues 243
Key Points 244
21. Techniques for Randomization 245
21.1 Requirements for a Valid Randomized Study 245
21.2 Creating a Randomization Schedule 246
21.3 Adding Special Features to the Randomization Schedule 249
21.3.1 Stratification 250
21.3.2 Blocking 252
21.3.3 Benefits and Pitfalls of Stratification and Blocking 254
21.4 Unbalanced Randomization 255
21.5 Ethical Issues 256
Key Points 257
22. Blinding in Interventional Studies 258
22.1 Why Blinding Is Used 258
22.2 The Hierarchy of Blinding 259
22.2.1 Double-Blind Studies 260
22.2.2 Complete Blinding 261
22.2.3 Single-Blind Studies 262
22.2.4 Open-Label Studies 264
22.2.5 Multiple Levels of Blinding 266
22.3 Monitoring Safety and Breaking the Blind 266
22.4 When the Blind Is Broken 267
22.5 Ethical Issues 268
Key Points 269
23. Techniques to Blind Interventional Studies 270
23.1 Masking the Intervention 270
23.1.1 Masking a Pharmaceutical Intervention 270
23.1.2 Maintaining the Mask When Dosage Levels Change 272
23.1.3 Masking a Non-Pharmaceutical Intervention 273
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Contents
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
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
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
Participants in Case-Control Studies
26.1 Identifying Cases and Controls
26.1.1 General Considerations
26.1.2 Identifying Cases
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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
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
27.5 Frequency Matching
27.6 Practical Issues
27.6.1 Overmatching
27.6.2 Excessive Matching Criteria
27.6.3 Special Problems
27.6.4 Data Analysis
27.7 Ethical Issues
Key Points
Blinding in Observational Studies
28.1 What Can Be Blinded?
28.2 Blinding of Written Records
28.3 Blinding When Assessors Have Contact with Participants
28.4 What to Do When Blinding Is Not Possible
28.5 Ethical Issues
Key Points
PART VI PRACTICAL ISSUES
Acquiring High Quality Data
29.1 Creating a Study ID
29.2 Methods for Data Collection
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Contents
29.2.1 Questionnaires 345
29.2.2 Open-Ended Data Collection by an Interviewer 348
29.2.3 Other Types of Procedures Done by Study Staff 351
29.2.4 Tests Done by Non-Study Staff 353
29.3 The Manual of Procedures (MOP) 354
29.4 Ensuring Validity in a Multi-Site Study 354
29.5 Ethical Issues 355
Key Points 356
30. Data Management 358
30.1 Basic Approaches to Data Storage 358
30.2 Documenting the Data 362
30.2.1 Data Organization and Coding 362
30.2.2 The Code Book 363
30.3 Selecting a Data Storage Program 364
30.4 Methods of Data Capture 365
30.5 Verifying Data 367
30.6 Preserving Confidentiality 371
30.7 A Note on Programs 373
30.8 Ethical Issus 373
Key Points 374
APPENDIXES STATISTICAL CONCEPTS 375
Appendix A. Hypothesis Testing 377
A.l The Criminal Trial as an Analogy for Hypothesis Testing 377
A.2 Hypothesis Testing 378
A.3 Determining Statistical Significance 383
A.4 Clinical Importance 386
A. 5 Ethical Issues 387
Key Points 388
Appendix B. Determining the Sample Size for a Study 390
B. l Why Sample Size Matters 390
B.2 Calculating a “just Right Number” 391
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Contents
B.3 The Problem with the “just Right Number” 393
B.4 Legitimate Ways to Reduce the “just Right Number” 394
B.5 The Magical Thinking Way to Reduce the “just Right Number” 397
B.6 An Alternative Way of Thinking about Sample Size 398
B.7 Ratio of Sample Sizes between Different Groups 399
B.8 Calculating the “just Right Number” 400
B.9 Ethical Issues 400
Key Points 401
Index 403
Planning a clinical study is much more than deciding on 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 these data? How will you minimize
bias? All these decisions must be consistent with the ethical considerations
of studying people.
Drawing on their many years working in clinical research, Robert A. Parker
and Nancy G. Berman guide the 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 and 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.
DR. ROBERT A. PARKER has been a consulting biostatistician for nearly
40 years. He has worked in academic medicine, industry (a Top 25 global
pharmaceutical company), and government (World Health Organization;
U.S. Centers for Disease Control). In industry, he was the arbiter of statisti-
cal methods for more than 100 statisticians in the company. Having worked
with junior investigators for most of his professional life, he is dedicated to
mentoring the next generation of medical researchers. This book reflects his
passion to train junior investigators in the art of clinical research.
DR. NANCY GREENE BERMAN has been a consulting biostatistician for
more than 35 years. She has worked in private consulting for the National
Institute of Health and other government studies. In Los Angeles, she was
chairperson of the annual Statistical Workshop and Treasurer for the South-
ern California Statistical Association. As the GCRC statistician and consultant
at the Harbor-UCLA Medical Center, she worked with both junior and senior
investigators developing protocols for clinical studies. Doing this work she
identified the need for a book that would provide details of clinical design
in an accessible format for all investigators. This book is intended to fulfill
that need.
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| id | DE-604.BV043954394 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T07:39:37Z |
| institution | BVB |
| isbn | 9780521840637 9780521549950 |
| language | English |
| lccn | 016024185 |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-029363186 |
| oclc_num | 1073740193 |
| open_access_boolean | |
| owner | DE-355 DE-BY-UBR |
| owner_facet | DE-355 DE-BY-UBR |
| publishDate | 2016 |
| publishDateSearch | 2016 |
| publishDateSort | 2016 |
| publisher | Cambridge University Press |
| record_format | marc |
| spelling | Parker, Robert A. 1949- Verfasser (DE-588)1119373123 aut Planning clinical research Robert A. Parker, (Harvard Medical School), Nancy Greene Berman (School of Public Health, UCLA Los Angeles) New York, NY, USA Cambridge University Press [2016] txt rdacontent n rdamedia nc rdacarrier Includes bibliographical references and index MEDICAL / Epidemiology bisacsh Medizin Clinical medicine Research Clinical trials MEDICAL / Epidemiology Klinisches Experiment (DE-588)4164223-5 gnd rswk-swf Forschungsplanung (DE-588)4155051-1 gnd rswk-swf Klinisches Experiment (DE-588)4164223-5 s Forschungsplanung (DE-588)4155051-1 s DE-604 Berman, Nancy Greene 1937- Verfasser (DE-588)1119373352 aut Digitalisierung UB Regensburg - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029363186&sequence=000003&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis Digitalisierung UB Regensburg - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029363186&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Klappentext |
| spellingShingle | Parker, Robert A. 1949- Berman, Nancy Greene 1937- Planning clinical research MEDICAL / Epidemiology bisacsh Medizin Clinical medicine Research Clinical trials MEDICAL / Epidemiology Klinisches Experiment (DE-588)4164223-5 gnd Forschungsplanung (DE-588)4155051-1 gnd |
| subject_GND | (DE-588)4164223-5 (DE-588)4155051-1 |
| title | Planning clinical research |
| title_auth | Planning clinical research |
| title_exact_search | Planning clinical research |
| title_full | Planning clinical research Robert A. Parker, (Harvard Medical School), Nancy Greene Berman (School of Public Health, UCLA Los Angeles) |
| title_fullStr | Planning clinical research Robert A. Parker, (Harvard Medical School), Nancy Greene Berman (School of Public Health, UCLA Los Angeles) |
| title_full_unstemmed | Planning clinical research Robert A. Parker, (Harvard Medical School), Nancy Greene Berman (School of Public Health, UCLA Los Angeles) |
| title_short | Planning clinical research |
| title_sort | planning clinical research |
| topic | MEDICAL / Epidemiology bisacsh Medizin Clinical medicine Research Clinical trials MEDICAL / Epidemiology Klinisches Experiment (DE-588)4164223-5 gnd Forschungsplanung (DE-588)4155051-1 gnd |
| topic_facet | MEDICAL / Epidemiology Medizin Clinical medicine Research Clinical trials Klinisches Experiment Forschungsplanung |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029363186&sequence=000003&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029363186&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT parkerroberta planningclinicalresearch AT bermannancygreene planningclinicalresearch |