Principles and practice of clinical research:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Amsterdam [u.a.]
Elsevier, Acad. Press
2007
|
| Ausgabe: | 2. ed. |
| Schlagworte: | |
| Online-Zugang: | Table of contents only Publisher description Inhaltsverzeichnis Klappentext |
| Beschreibung: | Nebentitel: Clinical research |
| Beschreibung: | XVI, 430 S. Ill., graph. Darst. |
| ISBN: | 9780123694409 012369440X |
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| 245 | 1 | 0 | |a Principles and practice of clinical research |c John I. Gallin ; Frederick P. Ognibene |
| 246 | 1 | 3 | |a Clinical research |
| 250 | |a 2. ed. | ||
| 264 | 1 | |a Amsterdam [u.a.] |b Elsevier, Acad. Press |c 2007 | |
| 300 | |a XVI, 430 S. |b Ill., graph. Darst. | ||
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Datensatz im Suchindex
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|---|---|
| adam_text |
Table
of
Contents
Preface
xi
Acknowledgements
xiii
Contributors
xv
CHAPTER
A Historical Perspective on
Clinical Research
JOHN I.
GALLIN
1.
The Earliest Clinical Research
1
2.
The Greek and Roman Influence
2
3.
Middle Ages and Renaissance
2
4.
Seventeenth Century
3
5.
Eighteenth Century
4
6.
Nineteenth Century
6
7.
Twentieth Century and Beyond
10
3.
History of Ethical Attention to
Clinical Research
16
4.
Codes of Research Ethics and Regulations
17
5.
Ethical Framework for Clinical Research
18
6.
Ethical Considerations in Randomized
Clinical Trials
23
7.
Conclusion
25
CHAPTER
Researching a Bioethical Question
EZEKIEL J.
EMANUEL
1.
Types of Bioethical Issues
27
2.
Types of Bioethical Research Methodologies
27
3.
Examples of Important Bioethical Research
28
4.
Special Considerations in Bioethical Research
35
CHAPTER
PART
I
ETHICAL, REGULATORY, AND
LEGAL ISSUES
CHAPTER
Ethical Principles in Clinical Research
CHRISTINE
GRADY
1.
Distinguishing Clinical Research from
Clinical Practice
15
2.
What Does Ethics Have to Do with
Clinical Research?
15
Integrity in Research: Individual and
Institutional Responsibility
JOAN P. SCHWARTZ
1.
Guidelines for the Conduct of Research
39
2.
Scientific Integrity and Misconduct
40
3.
Mentor-Trainee Relationships
41
4.
Data Acquisition, Management, Sharing,
and Ownership
41
5.
Research Involving Human and
Animal Subjects
42
6.
Collaborative Science
42
7.
Conflict of Interest and Commitment
43
8.
Peer Review
44
9.
Publication Practices and Responsible
Authorship
44
VI
Table of Contents
CHAPTER
CHAPTER
Institutional Review Boards
ALISON WICHMAN
1.
Historical, Ethical, and Regulatory Foundations
of Current Requirements for Research Involving
Human Subjects
47
2.
Institutional Review Boards
50
3.
Clinical Researchers and IRBs
56
4.
The Current IRB System Under Evaluation
56
5.
Conclusion
57
CHAPTER
Data and Safety Monitoring Boards
LAWRENCE M. FRIEDMAN
1.
Description of the Data and Safety
Monitoring Board
59
2.
Data and Safety Monitoring Board Functions
60
3.
Data and Safety Monitoring Board
Decision Making
61
4.
Examples
62
5.
Conclusions
64
CHAPTER
Data Management in Clinical Trials
ANNE TOMPKINS
1.
The Research Team
67
2.
Planning the Trial
69
3.
Where Are Data?
69
4.
Who Can Collect Data?
69
5.
Site Initiation Visit
70
6.
Informed Consent
70
7.
Eligibility
70
8.
Registration
71
9.
What Data Do You Collect?
71
10.
Treatment Plan
72
11.
Concurrent Therapy
72
12.
Adverse Event Monitoring
74
13.
Routine Monitoring Visits
74
14.
Audit Trail
75
15.
Electronic Database
75
16.
Summary
75
8
Unanticipated Risk in Clinical Research
STEPHEN E. STRAUS
1.
The Reasons
78
2.
The Drug
79
3.
The Target
81
4.
The Trials
81
5.
Cassandra Revealed
82
6.
Extended Studies
83
7.
FIAU
Toxicity
83
8.
Reassessing the Preclinical Studies
84
9.
Research Oversight
85
10.
The Investigations Begin
86
11.
Scientific Misconduct
86
12.
The FDA
87
13.
The National Institutes of Health
88
14.
The Institute of Medicine
88
15.
The Media
89
16.
The Congress
90
17.
The Law
90
18.
Epilogue
91
CHAPTER
The Regulation of Drugs and
Biological Products by the Food and
Drug Administration
KATHRYN
С
ZOON
AND ROBERT A. YETTER
1.
Introduction
97
2.
Background
97
3.
Mission, Organization, and Terminology
98
4.
Drug and Biologic Life Cycle
100
5.
Summary
107
CHAPTER
iõ
Legal Issues
PATRICIA A. KVOCHAK
1.
Legal Issues Related to Informed Consent for
Clinical and Research Care
109
2.
Advance Directives/Substitute Consent
110
3.
Children in Research
112
4.
Medical/Research Records
113
5.
Confidentiality
113
Table
of
Contents
VU
6.
Legal Liability
114
7.
Conflict of Interest
115
8.
Authorship/Rights in Data
Appendix
118
116
8.
Women of Childbearing Potential, Pregnant
Women, and Children
137
9.
Future Questions
138
10.
Conclusions
139
CHAPTER
11
Rules to Prevent Conflict of Interest for
Clinical Investigators Conducting Human
Subjects Research
ROBERT B. NUSSENBLATT AND MICHAEL
M. GOTTESMAN
1.
Preventing Conflict of Interest in Clinical Research
in the
NIH
Intramural Research Program
122
2.
Preventing Conflict of Interest by Members of
Institutional Review Boards
123
Appendix
I. What Are a Clinical Investigator's Potential
Conflicts of Interest?
124
II. To Whom Does the Guide Apply?
124
III. Examples of Investigator and IRB Financial
Conflicts of Interest
124
IV. Examples of Non-Financial Conflicts of Interest
for IRB's and Their Members
125
V. NIH's System to Assist in Identifying and
Preventing Financial Conflicts for Investigators
in Clinical Research
125
VI. IRB Clearance for
COI
126
VII.
NIH
Intellectual Property and Royalties
126
CHAPTER
І2
National Institutes of Health Policy on
the Inclusion of Women and Minorities as
Subjects in Clinical Research
MIRIAM
KELTY,
ANGELA BATES, AND VIVIAN W. PINN
1.
NIH
Policy
130
2.
Focus on Scientific Considerations
132
3.
Role of the
NIH
Office of Research on
Women's Health
132
4.
Role of Peer Review
133
5.
Role of the Institutional Review Board
134
6.
Role of Volunteers and Their Communities
134
7.
Demographic Data on Subject Enrollment
136
CHAPTER
13
Clinical Research: A Patient Perspective
SUSAN LOWELL BUTLER
1.
The Patient-Scientist Partnership
143
2.
Walking Away: Why Patients Refuse to Participate
in Clinical Trials
145
3.
The Trial Begins: Understanding the
Patient Experience
147
4.
Understanding the Caregiver
149
5.
The Role of Palliative Care
149
6.
Managing Difficult News
150
7.
Effective Patient Communications:
Recommendations and Considerations
151
8.
The Assertive Patient: Ally in
Scientific Research
152
9.
Conclusion
153
CHAPTER
П
The Clinical Researcher and the Media
JOHN BURKLOW
1.
What Makes News in Science and
Medicine?
156
2.
Why Talk to Reporters?
157
3.
Why Reporters Want to Talk to You
157
4.
Why You Should Talk to Reporters
158
5.
Engaging The Media: The Process
158
6.
A Word about E-mail and the Internet
159
7.
The Interview
159
8.
What If You Are Misquoted?
161
9.
What the Public Does Not Know
About Science
161
10.
Unexpected Questions
161
11.
When the News Is Not Good
161
12.
A Word About Investigative Reporters
162
13.
The Freedom of Information Act
162
14.
Embargoes
162
15.
The Ingelfinger Rule
163
16.
Clinical Alerts
163
17.
When to Contact Your
Communications Office
163
18.
Conclusion
163
Vlil
Table of Contents
PART
II
BIOSTATISTICS AND
EPIDEMIOLOGY
CHAPTER
15
An Introduction to Biostatistics:
Randomization, Hypothesis Testing, and
Sample Size Estimation
LAURA LEE JOHNSON, CRAIG
B.
BORKOWF,
AND PAUL S. ALBERT
1.
Introduction
165
2.
Issues in Randomization
167
3.
Overview of Hypothesis Testing
4.
Sample Size and Power
186
5.
Special Considerations
192
6.
Conclusion
195
CHAPTER
174
16
Design and Conduct of Observational
Studies and Clinical Trials
JACK M. GURALNIK AND
TERI A. MANOLIO
1.
Types of
Epidemiologìe
Study Designs
197
2.
Ecological (Correlational) Studies
198
3.
Case Reports and Case Series
199
4.
Prevalence Surveys or
Cross-Sectional Studies
199
5.
Case-Control Studies
201
6.
Prospective or Longitudinal Cohort Studies
205
7.
Causal Inference in Observational Studies
207
8.
Clinical Trials
207
9.
Conduct of
Epidemiologie
Studies: The
Study Protocol
210
CHAPTER
_
Small Clinical Trials
MITCHELL B. MAX
1.
Introduction
219
2.
Where We Are in the Short History of Controlled
Clinical Trials
219
3.
Explanatory Versus Pragmatic Orientation
in Clinical Trials: Implications for
Study Design
220
4.
Issues in Small Clinical Trials That Examine
Both Disease Mechanism and
Treatment Efficacy
221
5.
Placebo Responses in Clinical Trials
228
6.
Conclusion
233
CHAPTER
18
Large Clinical Trials and
Registries
—
Clinical
Research Institutes
ROBERT M. CALIFF
1.
Introduction
237
2.
History
237
3.
Phases of Evaluation of Therapies
238
4.
Critical General Concepts
238
5.
Expressing Clinical Trial Results
239
6.
Concepts Underlying Trial Design
242
7.
General Design Considerations
244
8.
Legal and Ethical Issues
245
9.
Hypothesis Formulation
249
10.
Publication Bias
250
11.
Statistical Considerations
250
12.
Meta-
Analysis and Systematic Overviews
252
13.
Understanding Covariates and Subgroups
253
14.
Therapeutic Truisms
254
15.
Study Organization
255
16.
Integration into Practice
258
17.
Controversies and Personal Perspective
258
18.
The Future
261
CHAPTER
19
Using Secondary Data in
Statistical Analysis
BRADLEY D. FREEMAN, STEVEN BANKS,
AND CHARLES NATANSON
1.
Techniques of Meta-Analysis
265
2.
Meta-Analysis of Clinical Trials of
Anti-Inflammatory Agents
in Sepsis
267
3.
Conclusions
268
Table
of
Contents
ЇХ
CHAPTER
20
An Introduction to Survival Analysis
LAURA LEE JOHNSON AND JOANNA H. SHIH
1.
Features of Survival Data
273
2.
Survival Function
274
3.
Special Considerations
280
4.
Conclusion
281
CHAPTER
21
Measures of Function and Health-Related
Quality of Life
LYNN H.
GERBER
1.
Introduction to Function and Quality of Life
2.
Definition of Quality of Life
284
3.
Health-Related Quality of Life Measures
285
4.
Other Instruments to Consider
288
5.
Importance of Quality of Life Measures for
Health Care
288
PART
283
III
TECHNOLOGY TRANSFER,
PROTOCOL DEVELOPMENT,
FUNDING AND OTHER ISSUES
CHAPTER
22
Overview of Technology Development
BRUCE GOLDSTEIN
1.
Introduction
291
2.
Scenario: Disasters Waiting to Happen
292
3.
The First and Biggest Mistake: Signing
the Agreements
293
4.
Agreements Not to Disclose: Trade Secrets and
the Confidential Disclosure Agreement
295
5.
Agreements to Transfer Materials
298
6.
Collaboration and Inventions: The Cooperative
Research and Development Agreement
303
7.
Proprietary Materials: The Materials CRADA
308
8.
Trademarks and Copyrights for the
Government Scientist
309
9.
Conclusion
311
CHAPTER
23
Technology Transfer
JACK SPIEGEL
1.
What Is Technology Transfer?
315
2.
Patents as Intellectual Property
315
3.
Rationale for Using Patents
316
4.
Historical Beginnings of Patents
318
5. 35
U.S.C.
101:
Concepts of New and Useful
319
6. 35
U.S.C.
102:
Concept of Novelty
321
7. 35
U.S.C.
103:
Concept of Obviousness
325
8.
More Is Needed to Establish the Quid
Pro Quo
326
9. 35
U.S.C.
112
and the Need to Know
326
10.
Procedures for Prosecuting a Patent Application
at the USPTO
328
11.
Obtaining Foreign Patents
329
12.
The
NIH
Path to Filing Patent Applications
330
13.
The
NIH
Licensing Process
332
14.
Other
OTT
Functions
333
15.
Conclusion: The Measure of
NIH
Technology
Transfer Is Its Success
333
CHAPTER
24
Writing a Protocol
ROBERT B. NUSSENBLATT
1.
Types of Protocols
335
2.
Writing a Protocol
335
3.
What Happens to Your Protocol?
336
4.
Essential Elements to the Protocol
336
CHAPTER
25
Evaluating a Protocol Budget
MARGARET
A. MATULA
1.
Introduction
341
2.
Requirements
341
Table
of
Contents
3.
Establishing
a Protocol Budget
4.
Summary
348
346
CHAPTER
CHAPTER
26
Data Management
in Clinical
Research:
General
Principles and
a Guide
to
Sources
STEPHEN J.
ROSENFELD
1.
Introduction
351
2.
The Dimensions of Data
351
3.
Kinds of Data
352
4.
General Considerations
353
5.
Documents That Govern Data Management
353
6.
Summary
357
CHAPTER
27
Getting the Funding You Need to
Support Your Research: Navigating
the National Institutes of Health Peer
Review Process
OLIVIA T. BARTLETT AND ELLIOT
POSTÓW
1.
Overview of
NIH
360
2.
The
NIH
Peer Review Process for Grants
365
3.
Hints for Preparing Better
Grant Applications
373
4.
NIH
Award Mechanisms for Support of Clinical
Researchers at Various Stages in
Their Careers
383
5.
Other
NIH
Programs for Clinical Researchers
386
6.
New Directions and Initiatives at
NIH
388
7.
How to Stay Informed about the
NIH
Peer
Review System
390
28
Clinical Research from the
Industry Perspective
DENISE T. RESNIK
1.
Components of the Pharmaceutical Industry
391
2.
Issues Impacting Industry Clinical Research
396
3.
Industry Outlook
401
4.
Summary
402
CHAPTER
29
Human Genome Project, Genomics, and
Clinical Research
HELEN
N. LYON
AND BRUCE R.
KORF
1.
Overview
405
2.
Genetic Models
406
3.
Complex Trait Dissection
407
4.
Sample Collection and Informed Consent
408
5.
Approach to Genotyping
410
6.
Linkage Analysis (Parametric)
411
7.
Nonparametric Analysis
413
8.
Association and Linkage Disequilibrium
414
9.
Gene Identification
417
10.
Integration of Genetics into
Medical Practice
418
11.
Summary
419
Index
421
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing
input from experts on the principles and practice of clinical research. As an introductory reference it gives clinical investigators in all
fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory
fequirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research
and ethics, copious figures and charts, and sample documents, this remarkably comprehensive reference serves as an excellent
companion text for any course on clinical research and as a must-have reference for seasoned researchers.
HIGHLIGHTS
•
Incorporates new chapters: Managing Conflicts of Interest in Human Subjects Research, Clinical Research
from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research,
Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research
•Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research
•
Delves into data management and addresses how to collect data and use it for discovery
•
Contains valuable, up-to-date information on how to obtain funding from the federal government
ABOUT THE EDITORS
Dr.
Gallin
is an active clinician, researcher, and administrator. He served as Scientific Director, National Institute of Allergy
and Infectious Diseases (NIAID) from
1985-1994.
He was Chief of the Laboratory of Host Defenses, NIAID, from
1991—
2003.
Dr.
Gallin
has authored over
300
research articles and also edited the textbook Inflammation, Basic Principles and
Clinical Correlates, In
1994,
Dr.
Gallin
was appointed to his current position as Director of the
NIH
Clinical Center. His
awards include: the Young Investigator Award of the American Federation for Clinical Research, the Squibb Award of the
Infectious Disease Society of America, the American College of Physicians Richard and
Hinda
Rosen thai Award, and the
USPHS Award for orphan product development. In
2001,
he received the Physician Executive of the Year Award from the
USPHS, and in
2006
the DHHS Secretary's Award for Distinguished Service. Dr.
Gallin
is a member of the American Society
for Clinical Investigation, the Association of American Physicians, the American Clinical and Climatological Association, and
the Institute of Medicine of the National Academy of Sciences.
Dr. Ogmbene is also an active physician-scientist and administrator. He is a senior investigator at the
NIH
and, since
2003,
Director of the Office of Clinical Research Training and Medical Education at the
NIH
Clinical Center. Dr. Ognibene is also
Director of the Clinical Research Training Program for medical and dental students at the
NIH.
Dr. Ognibene has authored
nearly
100
research articles and invited manuscripts. He is a member of several professional societies and will be president of
the Society of Critical Care Medicine
m
2007.
His honors and awards include: the Public Health Service Outstanding Service
Medal, two
NIH
Clinical Center Directors Awards, the
NIH
Directors Award for Mentoring, and Who's Who in America. |
| adam_txt |
Table
of
Contents
Preface
xi
Acknowledgements
xiii
Contributors
xv
CHAPTER
A Historical Perspective on
Clinical Research
JOHN I.
GALLIN
1.
The Earliest Clinical Research
1
2.
The Greek and Roman Influence
2
3.
Middle Ages and Renaissance
2
4.
Seventeenth Century
3
5.
Eighteenth Century
4
6.
Nineteenth Century
6
7.
Twentieth Century and Beyond
10
3.
History of Ethical Attention to
Clinical Research
16
4.
Codes of Research Ethics and Regulations
17
5.
Ethical Framework for Clinical Research
18
6.
Ethical Considerations in Randomized
Clinical Trials
23
7.
Conclusion
25
CHAPTER
Researching a Bioethical Question
EZEKIEL J.
EMANUEL
1.
Types of Bioethical Issues
27
2.
Types of Bioethical Research Methodologies
27
3.
Examples of Important Bioethical Research
28
4.
Special Considerations in Bioethical Research
35
CHAPTER
PART
I
ETHICAL, REGULATORY, AND
LEGAL ISSUES
CHAPTER
Ethical Principles in Clinical Research
CHRISTINE
GRADY
1.
Distinguishing Clinical Research from
Clinical Practice
15
2.
What Does Ethics Have to Do with
Clinical Research?
15
Integrity in Research: Individual and
Institutional Responsibility
JOAN P. SCHWARTZ
1.
Guidelines for the Conduct of Research
39
2.
Scientific Integrity and Misconduct
40
3.
Mentor-Trainee Relationships
41
4.
Data Acquisition, Management, Sharing,
and Ownership
41
5.
Research Involving Human and
Animal Subjects
42
6.
Collaborative Science
42
7.
Conflict of Interest and Commitment
43
8.
Peer Review
44
9.
Publication Practices and Responsible
Authorship
44
VI
Table of Contents
CHAPTER
CHAPTER
Institutional Review Boards
ALISON WICHMAN
1.
Historical, Ethical, and Regulatory Foundations
of Current Requirements for Research Involving
Human Subjects
47
2.
Institutional Review Boards
50
3.
Clinical Researchers and IRBs
56
4.
The Current IRB System Under Evaluation
56
5.
Conclusion
57
CHAPTER
Data and Safety Monitoring Boards
LAWRENCE M. FRIEDMAN
1.
Description of the Data and Safety
Monitoring Board
59
2.
Data and Safety Monitoring Board Functions
60
3.
Data and Safety Monitoring Board
Decision Making
61
4.
Examples
62
5.
Conclusions
64
CHAPTER
Data Management in Clinical Trials
ANNE TOMPKINS
1.
The Research Team
67
2.
Planning the Trial
69
3.
Where Are Data?
69
4.
Who Can Collect Data?
69
5.
Site Initiation Visit
70
6.
Informed Consent
70
7.
Eligibility
70
8.
Registration
71
9.
What Data Do You Collect?
71
10.
Treatment Plan
72
11.
Concurrent Therapy
72
12.
Adverse Event Monitoring
74
13.
Routine Monitoring Visits
74
14.
Audit Trail
75
15.
Electronic Database
75
16.
Summary
75
8
Unanticipated Risk in Clinical Research
STEPHEN E. STRAUS
1.
The Reasons
78
2.
The Drug
79
3.
The Target
81
4.
The Trials
81
5.
Cassandra Revealed
82
6.
Extended Studies
83
7.
FIAU
Toxicity
83
8.
Reassessing the Preclinical Studies
84
9.
Research Oversight
85
10.
The Investigations Begin
86
11.
Scientific Misconduct
86
12.
The FDA
87
13.
The National Institutes of Health
88
14.
The Institute of Medicine
88
15.
The Media
89
16.
The Congress
90
17.
The Law
90
18.
Epilogue
91
CHAPTER
The Regulation of Drugs and
Biological Products by the Food and
Drug Administration
KATHRYN
С
ZOON
AND ROBERT A. YETTER
1.
Introduction
97
2.
Background
97
3.
Mission, Organization, and Terminology
98
4.
Drug and Biologic Life Cycle
100
5.
Summary
107
CHAPTER
iõ
Legal Issues
PATRICIA A. KVOCHAK
1.
Legal Issues Related to Informed Consent for
Clinical and Research Care
109
2.
Advance Directives/Substitute Consent
110
3.
Children in Research
112
4.
Medical/Research Records
113
5.
Confidentiality
113
Table
of
Contents
VU
6.
Legal Liability
114
7.
Conflict of Interest
115
8.
Authorship/Rights in Data
Appendix
118
116
8.
Women of Childbearing Potential, Pregnant
Women, and Children
137
9.
Future Questions
138
10.
Conclusions
139
CHAPTER
11
Rules to Prevent Conflict of Interest for
Clinical Investigators Conducting Human
Subjects Research
ROBERT B. NUSSENBLATT AND MICHAEL
M. GOTTESMAN
1.
Preventing Conflict of Interest in Clinical Research
in the
NIH
Intramural Research Program
122
2.
Preventing Conflict of Interest by Members of
Institutional Review Boards
123
Appendix
I. What Are a Clinical Investigator's Potential
Conflicts of Interest?
124
II. To Whom Does the Guide Apply?
124
III. Examples of Investigator and IRB Financial
Conflicts of Interest
124
IV. Examples of Non-Financial Conflicts of Interest
for IRB's and Their Members
125
V. NIH's System to Assist in Identifying and
Preventing Financial Conflicts for Investigators
in Clinical Research
125
VI. IRB Clearance for
COI
126
VII.
NIH
Intellectual Property and Royalties
126
CHAPTER
І2
National Institutes of Health Policy on
the Inclusion of Women and Minorities as
Subjects in Clinical Research
MIRIAM
KELTY,
ANGELA BATES, AND VIVIAN W. PINN
1.
NIH
Policy
130
2.
Focus on Scientific Considerations
132
3.
Role of the
NIH
Office of Research on
Women's Health
132
4.
Role of Peer Review
133
5.
Role of the Institutional Review Board
134
6.
Role of Volunteers and Their Communities
134
7.
Demographic Data on Subject Enrollment
136
CHAPTER
13
Clinical Research: A Patient Perspective
SUSAN LOWELL BUTLER
1.
The Patient-Scientist Partnership
143
2.
Walking Away: Why Patients Refuse to Participate
in Clinical Trials
145
3.
The Trial Begins: Understanding the
Patient Experience
147
4.
Understanding the Caregiver
149
5.
The Role of Palliative Care
149
6.
Managing Difficult News
150
7.
Effective Patient Communications:
Recommendations and Considerations
151
8.
The Assertive Patient: Ally in
Scientific Research
152
9.
Conclusion
153
CHAPTER
П
The Clinical Researcher and the Media
JOHN BURKLOW
1.
What Makes News in Science and
Medicine?
156
2.
Why Talk to Reporters?
157
3.
Why Reporters Want to Talk to You
157
4.
Why You Should Talk to Reporters
158
5.
Engaging The Media: The Process
158
6.
A Word about E-mail and the Internet
159
7.
The Interview
159
8.
What If You Are Misquoted?
161
9.
What the Public Does Not Know
About Science
161
10.
Unexpected Questions
161
11.
When the News Is Not Good
161
12.
A Word About Investigative Reporters
162
13.
The Freedom of Information Act
162
14.
Embargoes
162
15.
The Ingelfinger Rule
163
16.
Clinical Alerts
163
17.
When to Contact Your
Communications Office
163
18.
Conclusion
163
Vlil
Table of Contents
PART
II
BIOSTATISTICS AND
EPIDEMIOLOGY
CHAPTER
15
An Introduction to Biostatistics:
Randomization, Hypothesis Testing, and
Sample Size Estimation
LAURA LEE JOHNSON, CRAIG
B.
BORKOWF,
AND PAUL S. ALBERT
1.
Introduction
165
2.
Issues in Randomization
167
3.
Overview of Hypothesis Testing
4.
Sample Size and Power
186
5.
Special Considerations
192
6.
Conclusion
195
CHAPTER
174
16
Design and Conduct of Observational
Studies and Clinical Trials
JACK M. GURALNIK AND
TERI A. MANOLIO
1.
Types of
Epidemiologìe
Study Designs
197
2.
Ecological (Correlational) Studies
198
3.
Case Reports and Case Series
199
4.
Prevalence Surveys or
Cross-Sectional Studies
199
5.
Case-Control Studies
201
6.
Prospective or Longitudinal Cohort Studies
205
7.
Causal Inference in Observational Studies
207
8.
Clinical Trials
207
9.
Conduct of
Epidemiologie
Studies: The
Study Protocol
210
CHAPTER
_
Small Clinical Trials
MITCHELL B. MAX
1.
Introduction
219
2.
Where We Are in the Short History of Controlled
Clinical Trials
219
3.
Explanatory Versus Pragmatic Orientation
in Clinical Trials: Implications for
Study Design
220
4.
Issues in Small Clinical Trials That Examine
Both Disease Mechanism and
Treatment Efficacy
221
5.
Placebo Responses in Clinical Trials
228
6.
Conclusion
233
CHAPTER
18
Large Clinical Trials and
Registries
—
Clinical
Research Institutes
ROBERT M. CALIFF
1.
Introduction
237
2.
History
237
3.
Phases of Evaluation of Therapies
238
4.
Critical General Concepts
238
5.
Expressing Clinical Trial Results
239
6.
Concepts Underlying Trial Design
242
7.
General Design Considerations
244
8.
Legal and Ethical Issues
245
9.
Hypothesis Formulation
249
10.
Publication Bias
250
11.
Statistical Considerations
250
12.
Meta-
Analysis and Systematic Overviews
252
13.
Understanding Covariates and Subgroups
253
14.
Therapeutic Truisms
254
15.
Study Organization
255
16.
Integration into Practice
258
17.
Controversies and Personal Perspective
258
18.
The Future
261
CHAPTER
19
Using Secondary Data in
Statistical Analysis
BRADLEY D. FREEMAN, STEVEN BANKS,
AND CHARLES NATANSON
1.
Techniques of Meta-Analysis
265
2.
Meta-Analysis of Clinical Trials of
Anti-Inflammatory Agents
in Sepsis
267
3.
Conclusions
268
Table
of
Contents
ЇХ
CHAPTER
20
An Introduction to Survival Analysis
LAURA LEE JOHNSON AND JOANNA H. SHIH
1.
Features of Survival Data
273
2.
Survival Function
274
3.
Special Considerations
280
4.
Conclusion
281
CHAPTER
21
Measures of Function and Health-Related
Quality of Life
LYNN H.
GERBER
1.
Introduction to Function and Quality of Life
2.
Definition of Quality of Life
284
3.
Health-Related Quality of Life Measures
285
4.
Other Instruments to Consider
288
5.
Importance of Quality of Life Measures for
Health Care
288
PART
283
III
TECHNOLOGY TRANSFER,
PROTOCOL DEVELOPMENT,
FUNDING AND OTHER ISSUES
CHAPTER
22
Overview of Technology Development
BRUCE GOLDSTEIN
1.
Introduction
291
2.
Scenario: Disasters Waiting to Happen
292
3.
The First and Biggest Mistake: Signing
the Agreements
293
4.
Agreements Not to Disclose: Trade Secrets and
the Confidential Disclosure Agreement
295
5.
Agreements to Transfer Materials
298
6.
Collaboration and Inventions: The Cooperative
Research and Development Agreement
303
7.
Proprietary Materials: The Materials CRADA
308
8.
Trademarks and Copyrights for the
Government Scientist
309
9.
Conclusion
311
CHAPTER
23
Technology Transfer
JACK SPIEGEL
1.
What Is Technology Transfer?
315
2.
Patents as Intellectual Property
315
3.
Rationale for Using Patents
316
4.
Historical Beginnings of Patents
318
5. 35
U.S.C.
101:
Concepts of New and Useful
319
6. 35
U.S.C.
102:
Concept of Novelty
321
7. 35
U.S.C.
103:
Concept of Obviousness
325
8.
More Is Needed to Establish the Quid
Pro Quo
326
9. 35
U.S.C.
112
and the Need to Know
326
10.
Procedures for Prosecuting a Patent Application
at the USPTO
328
11.
Obtaining Foreign Patents
329
12.
The
NIH
Path to Filing Patent Applications
330
13.
The
NIH
Licensing Process
332
14.
Other
OTT
Functions
333
15.
Conclusion: The Measure of
NIH
Technology
Transfer Is Its Success
333
CHAPTER
24
Writing a Protocol
ROBERT B. NUSSENBLATT
1.
Types of Protocols
335
2.
Writing a Protocol
335
3.
What Happens to Your Protocol?
336
4.
Essential Elements to the Protocol
336
CHAPTER
25
Evaluating a Protocol Budget
MARGARET
A. MATULA
1.
Introduction
341
2.
Requirements
341
Table
of
Contents
3.
Establishing
a Protocol Budget
4.
Summary
348
346
CHAPTER
CHAPTER
26
Data Management
in Clinical
Research:
General
Principles and
a Guide
to
Sources
STEPHEN J.
ROSENFELD
1.
Introduction
351
2.
The Dimensions of Data
351
3.
Kinds of Data
352
4.
General Considerations
353
5.
Documents That Govern Data Management
353
6.
Summary
357
CHAPTER
27
Getting the Funding You Need to
Support Your Research: Navigating
the National Institutes of Health Peer
Review Process
OLIVIA T. BARTLETT AND ELLIOT
POSTÓW
1.
Overview of
NIH
360
2.
The
NIH
Peer Review Process for Grants
365
3.
Hints for Preparing Better
Grant Applications
373
4.
NIH
Award Mechanisms for Support of Clinical
Researchers at Various Stages in
Their Careers
383
5.
Other
NIH
Programs for Clinical Researchers
386
6.
New Directions and Initiatives at
NIH
388
7.
How to Stay Informed about the
NIH
Peer
Review System
390
28
Clinical Research from the
Industry Perspective
DENISE T. RESNIK
1.
Components of the Pharmaceutical Industry
391
2.
Issues Impacting Industry Clinical Research
396
3.
Industry Outlook
401
4.
Summary
402
CHAPTER
29
Human Genome Project, Genomics, and
Clinical Research
HELEN
N. LYON
AND BRUCE R.
KORF
1.
Overview
405
2.
Genetic Models
406
3.
Complex Trait Dissection
407
4.
Sample Collection and Informed Consent
408
5.
Approach to Genotyping
410
6.
Linkage Analysis (Parametric)
411
7.
Nonparametric Analysis
413
8.
Association and Linkage Disequilibrium
414
9.
Gene Identification
417
10.
Integration of Genetics into
Medical Practice
418
11.
Summary
419
Index
421
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing
input from experts on the principles and practice of clinical research. As an introductory reference it gives clinical investigators in all
fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory
fequirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research
and ethics, copious figures and charts, and sample documents, this remarkably comprehensive reference serves as an excellent
companion text for any course on clinical research and as a must-have reference for seasoned researchers.
HIGHLIGHTS
•
Incorporates new chapters: Managing Conflicts of Interest in Human Subjects Research, Clinical Research
from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research,
Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research
•Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research
•
Delves into data management and addresses how to collect data and use it for discovery
•
Contains valuable, up-to-date information on how to obtain funding from the federal government
ABOUT THE EDITORS
Dr.
Gallin
is an active clinician, researcher, and administrator. He served as Scientific Director, National Institute of Allergy
and Infectious Diseases (NIAID) from
1985-1994.
He was Chief of the Laboratory of Host Defenses, NIAID, from
1991—
2003.
Dr.
Gallin
has authored over
300
research articles and also edited the textbook Inflammation, Basic Principles and
Clinical Correlates, In
1994,
Dr.
Gallin
was appointed to his current position as Director of the
NIH
Clinical Center. His
awards include: the Young Investigator Award of the American Federation for Clinical Research, the Squibb Award of the
Infectious Disease Society of America, the American College of Physicians Richard and
Hinda
Rosen thai Award, and the
USPHS Award for orphan product development. In
2001,
he received the Physician Executive of the Year Award from the
USPHS, and in
2006
the DHHS Secretary's Award for Distinguished Service. Dr.
Gallin
is a member of the American Society
for Clinical Investigation, the Association of American Physicians, the American Clinical and Climatological Association, and
the Institute of Medicine of the National Academy of Sciences.
Dr. Ogmbene is also an active physician-scientist and administrator. He is a senior investigator at the
NIH
and, since
2003,
Director of the Office of Clinical Research Training and Medical Education at the
NIH
Clinical Center. Dr. Ognibene is also
Director of the Clinical Research Training Program for medical and dental students at the
NIH.
Dr. Ognibene has authored
nearly
100
research articles and invited manuscripts. He is a member of several professional societies and will be president of
the Society of Critical Care Medicine
m
2007.
His honors and awards include: the Public Health Service Outstanding Service
Medal, two
NIH
Clinical Center Directors Awards, the
NIH
Directors Award for Mentoring, and Who's Who in America. |
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| publisher | Elsevier, Acad. Press |
| record_format | marc |
| spelling | Principles and practice of clinical research John I. Gallin ; Frederick P. Ognibene Clinical research 2. ed. Amsterdam [u.a.] Elsevier, Acad. Press 2007 XVI, 430 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Nebentitel: Clinical research Médecine clinique - Recherche Clinical medicine Research Research methods Klinische Medizin (DE-588)4134748-1 gnd rswk-swf Medizin (DE-588)4038243-6 gnd rswk-swf Forschung (DE-588)4017894-8 gnd rswk-swf Medizin (DE-588)4038243-6 s Forschung (DE-588)4017894-8 s DE-604 Klinische Medizin (DE-588)4134748-1 s 1\p DE-604 Gallin, John I. Sonstige oth Ognibene, Frederick P. Sonstige oth http://www.loc.gov/catdir/toc/ecip0710/2007004577.html Table of contents only http://www.loc.gov/catdir/enhancements/fy0708/2007004577-d.html Publisher description Digitalisierung UB Regensburg application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016246411&sequence=000003&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis Digitalisierung UB Regensburg application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016246411&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Klappentext 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Principles and practice of clinical research Médecine clinique - Recherche Clinical medicine Research Research methods Klinische Medizin (DE-588)4134748-1 gnd Medizin (DE-588)4038243-6 gnd Forschung (DE-588)4017894-8 gnd |
| subject_GND | (DE-588)4134748-1 (DE-588)4038243-6 (DE-588)4017894-8 |
| title | Principles and practice of clinical research |
| title_alt | Clinical research |
| title_auth | Principles and practice of clinical research |
| title_exact_search | Principles and practice of clinical research |
| title_exact_search_txtP | Principles and practice of clinical research |
| title_full | Principles and practice of clinical research John I. Gallin ; Frederick P. Ognibene |
| title_fullStr | Principles and practice of clinical research John I. Gallin ; Frederick P. Ognibene |
| title_full_unstemmed | Principles and practice of clinical research John I. Gallin ; Frederick P. Ognibene |
| title_short | Principles and practice of clinical research |
| title_sort | principles and practice of clinical research |
| topic | Médecine clinique - Recherche Clinical medicine Research Research methods Klinische Medizin (DE-588)4134748-1 gnd Medizin (DE-588)4038243-6 gnd Forschung (DE-588)4017894-8 gnd |
| topic_facet | Médecine clinique - Recherche Clinical medicine Research Research methods Klinische Medizin Medizin Forschung |
| url | http://www.loc.gov/catdir/toc/ecip0710/2007004577.html http://www.loc.gov/catdir/enhancements/fy0708/2007004577-d.html http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016246411&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=016246411&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA |
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