Principles and practice of clinical research:
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
Amsterdam [u.a.]
Elsevier, Academic Press
2012
|
| Edition: | 3. ed. |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis Klappentext |
| Physical Description: | XV, 780 S. Ill., graph. Darst. |
| ISBN: | 9780123821676 0123821673 |
Staff View
MARC
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Record in the Search Index
| _version_ | 1804149111796006912 |
|---|---|
| adam_text | Contents
Contributors
ix
Preface
xiii
Acknowledgments
xv
1.
A Historical Perspective on Clinical
Research
1
John I.
Gallin
Part I
Ethical, Regulatory and Legal Issues
2.
Ethical Principles in Clinical
Research
19
Christine
Grady
3.
Researching a Bioethical Question
31
EzekielJ.
Emanuel
4.
Integrity in Research: Individual
and Institutional Responsibility
43
Melissa C. Colbert
5.
Institutional Review Boards
53
Alison Wichman
6.
The Role of Independent
Institutional Review Boards
67
Stephen J.
Rosenfeld
7.
The Regulation of Drugs and
Biological Products by the Food
and Drug Administration
79
Kathryn
С
Zoon
and Robert A. Yetter
8.
Data Management in Clinical Trials
91
Diane C. St. Germain
9.
Data and Safety Monitoring
101
Lawrence M. Friedman and
Dennis O. Dixon
10.
Unanticipated Risk in Clinical
Research
109
Stephen E. Straus
11.
Legal Issues
127
Patricia A. Kvochak
12.
Rules to Prevent Conflict of Interest
for Clinical Investigators Conducting
Human Subjects Research
139
Robert B.
Nüssen
blatt,
Melissa
С.
Colbert and
Michael M. Gottesman
13.
National Institutes of Health Policy
on the Inclusion of Women and
Minorities as Subjects in
Clinical Research
147
Miriam
Kelty,
Angela Bates and
Vivian W. P inn
14.
Accreditation of Human Research
Protection Programs
161
Marjorie
Speers
15.
The Role and Importance of
Clinical Trial Registries and
Results Databases
171
Tony Tse, Deborah A.
Zarin,
Rebecca
J. Williams and Nicholas
C. Ide
16.
The Clinical Researcher and
the Media
183
John T. Burklow
Contents
17.
Clinical
Research:
A
Patient
Perspective
Susan
Lowell
Butler
Part II
Biostatistics
and Epidemiology
18.
Design
of Observational Studies
Laura Lee Johnson
19. Design
of Clinical Studies
and Trials
Catherine M. Stoney and
Laura Lee Johnson
20.
Issues in Randomization
Pamela A. Shaw, Laura Lee Johnson
and Craig B. Borkowf
21.
Hypothesis Testing
Laura Lee Johnson, Craig B. Borkowf
and Pamela A. Shaw
22.
Power and Sample Size
Calculations
Craig B. Borkowf, Laura Lee Johnson
and Paul S. Albert
23.
An Introduction to Survival
Analysis
Laura Lee Johnson and
Joanna H. Shih
24.
Intermediate Topics in
Biostatistics
Pamela A. Shaw, Laura Lee Johnson
and Michael A.
Proschan
25.
Measures of Function and
Health-related Quality of Life
Lynn H.
Gerber
and
Julian
Kallman
Price
26.
Large Clinical Trials and
Registries—Clinical Research
Institutes
Robert M. Califf
27.
Meta-analysis of Clinical Trials
193
Junfeng Sun, Bradley D. Freeman
and Charles Natanson
28.
Using Large
Datasets
for
Population-based Health Research
Leighton Chan and Patrick McGarey
361
207
225
243
255
271
285
295
29.
Development and Conduct of
Studies
Catherine M. Stoney and
Laura Lee Johnson
Part III
Technology Transfer, Protocol
Development, and Funding
30.
Overview of Technology
Development
Bruce Goldstein
31.
Patents and Patent Licenses
Bruce Goldstein
32.
Writing a Protocol
Barbara
I. Karp
and
Robert B. Nussenblatt
33.
Evaluating a Protocol Budget
Margaret
A. Matula
34.
Clinical Research Data:
Characteristics, Representation,
Storage, and Retrieval
James J.
Cimino
371
381
397
419
483
491
35.
Management of Patient Samples
and Specimens
321
Karen E. Pitt and Amy P.N. Skubitz
36.
Getting the Funding You Need
to Support Your Research:
Navigating the National
Institutes of Health Peer
331
Review Process
Olivia T. Bartlett
501
509
519
Contents
37.
Clinical
Research
from the Industry
Perspective
539
Denise T.
Resnìk
38.
Philanthropic Sector Support for
Medical Research and Training:
History and Trends
555
Elaine
K. Gallin
and Nancy S. Sung
Part IV
Clinical Research Infrastructure
39.
Managing Clinical Risk and Measuring
Participants Perceptions of
the Clinical Research Process
573
Laura M. Lee, Jennifer Yessis,
Rhonda
G. Kost
and David K. Henderson
40.
Integration of Specialized Research
Services into Clinical Laboratory
Operations
589
Alan T. Remaley, Patrick R. Murray
and Thomas A. Fleisher
41.
Imaging in Clinical Trials
597
David A. Bluemke and Songtao Liu
42.
Role of Blood Bank and
Transfusion Medicine in Clinical
Research
619
Harvey G. Klein
43.
Clinical Pharmacology and its Role
in Pharmaceutical Development
627
Juan J.L. Lertora and
Konstantina
M. Vanevski
44.
Career Paths in Clinical Research
641
Frederick P. Ognibene
45.
Clinical Research Nursing:
A New Domain of Practice
649
Clare Hastings
46.
Clinical Research Applications of
Health Disparities Science in
Community Settings
665
Irene Dankwa-Mullan and Kyu
Bak
Louis Rhee
47.
Issues and Challenges for Clinical
Research in International Settings
689
Christopher O. Olopade,
Sope Olugbile
and
Olufunmilayo I. Olopade
48.
The Power of an Undiagnosed
Diseases Program in a Clinical
Research Enterprise
701
William A. Gahl
49.
Human Genome Project,
Genomics, and Clinical Research
707
Bruce R.
Korf
and Nianjun Liu
50.
Harnessing Information Using
Genomic Platforms
727
P. Suzanne Hart, Thomas
C. Markello
and William A. Gahl
Answer Key to Summary Questions
745
Principles and Practice of Clinical Research,
3rd
Edition Acronyms by Chapter
753
Index
765
research
organization or enterprise. With authors who are experts in clinical research in both die public and private sectors,
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| spelling | Principles and practice of clinical research ed. by John I. Gallin ... Clinical research 3. ed. Amsterdam [u.a.] Elsevier, Academic Press 2012 XV, 780 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Médecine clinique - Recherche Clinical medicine Research Research methods Forschung (DE-588)4017894-8 gnd rswk-swf Klinische Medizin (DE-588)4134748-1 gnd rswk-swf Medizin (DE-588)4038243-6 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. 1943- Sonstige (DE-588)172091438 oth Digitalisierung UB Regensburg application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=024999561&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=024999561&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 Forschung (DE-588)4017894-8 gnd Klinische Medizin (DE-588)4134748-1 gnd Medizin (DE-588)4038243-6 gnd |
| subject_GND | (DE-588)4017894-8 (DE-588)4134748-1 (DE-588)4038243-6 |
| 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_full | Principles and practice of clinical research ed. by John I. Gallin ... |
| title_fullStr | Principles and practice of clinical research ed. by John I. Gallin ... |
| title_full_unstemmed | Principles and practice of clinical research ed. by John I. Gallin ... |
| 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 Forschung (DE-588)4017894-8 gnd Klinische Medizin (DE-588)4134748-1 gnd Medizin (DE-588)4038243-6 gnd |
| topic_facet | Médecine clinique - Recherche Clinical medicine Research Research methods Forschung Klinische Medizin Medizin |
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