Statistical monitoring of clinical trials: fundamentals for investigators
Saved in:
| Main Author: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York, NY
Springer
2006
|
| Subjects: | |
| Online Access: | Klappentext Inhaltsverzeichnis |
| Item Description: | Includes bibliographical references and index |
| Physical Description: | XXI, 254 S. graph. Darst. |
| ISBN: | 0387277811 9780387277813 |
Staff View
MARC
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| 245 | 1 | 0 | |a Statistical monitoring of clinical trials |b fundamentals for investigators |c Lemuel A. Moyé |
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Record in the Search Index
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| adam_text | Contents
Preface
Acknowledgments
Contents
Introduction
1.
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8
1.9
1.10
1.11
1.12
1.13
1.14
1.15
1.16
1.17
1.18
1.19
References
2.
2.1
2.2
2.2.1
2.3
2.3.1
2.4
2.5
2.5.1
2.5.2
2.5.3
2.5.4
xiii
Table of
2.6
2.7
2.7.1
2.7.2
2.7.2.1
2.7.2.2
2.7.3
2.7.4
2.7.5
2.8
References
3.
3.1
3.2
3.3
3.4
3.4.1
3.4.2
3.4.3
3.4.4
3.4.5
3.4.6
3.4.7
3.4.8
3.5
3.5.1
3.5.2
3.6
3.6.1
3.6.2
3.6.2.1
3.6.2.2
3.7
Problems
References
4.
4.1
4.2
4.3.
4.3.1
4.3.2
4.3.3
4.4
4.4.1
4.4.2
4.4.3
4.4.4
Table of
4.4.5
4.4.6
4.4.7
4.5
4.5.1.
4.5.1.1
4.5.1.2
4.5.1.3
4.5.2
4.5.3
4.5.4
4.6
Problems
References
5.
5.1
5.2
5.3
5.4
5.4.1
5.4.2
5.5
5.6
5.6.1
5.6.2
5.6.3
5.7
5.7.1
5.7.1.1
5.7.2
Problems
References
6.
6.1
6.2
6.3
6.4.
6.5
6.6
6.7
6.7.1
6.8
6.9
Problems
References
Table of
7.
7.1
7.2
7.3
7.3.1
7.3.2
7.3.3
7.3.4
7.4
7.5
7.5.1
7.5.2
7.5.3
7.5.4
7.6
7.6.1
7.6.2
7.6.3
Problems
References
8.
8.1
8.2
8.2.1
8.2.2
8.2.3
8.3
8.4
8.5
Problems
References
Appendix A. Boundary Values for Normal Mean
Appendix B. Conditional Brownian Motion
B.I Nomenclature and Background Mathematics
B.I.I Notation
B.1.2Multivariate Normal Distributions
B.2 Covariance and Brownian Motion Elements
B.3 Brownian Motion Conditioned on the Past
B.4 Brownian Motion Conditioned on the Past and Future
Appendix C. Boundary Values and Conditional Power
C.I Monitoring for Efficacy or Harm
C.2 Calculation for Futility
Appendix D. Supporting Bayesian Computations
xvii Table of Contents
D.I.
Appendix E. Standard Normal Probabilities
Index
Statistical Monitoring of Clinical Trials: Fundamentals for Investigators intro¬
duces the investigator and statistician to monitoring procedures in clinical
research. Clearly presenting the necessary background with limited use of mathe¬
matics, this book increases the knowledge, experience, and intuition of investiga¬
tions in the use of these important procedures now required by the many clinical
research efforts.
The author provides motivated clinical investigators the background, correct use,
and interpretation of these monitoring procedures at an elementary statistical
level. He defines terms commonly used such as group sequential procedures and
stochastic curtailment in non-mathematical language and discusses the common¬
ly used procedures of Pocock, O Brien-Fleming, and Lan-DeMets. He discusses the
notions of conditional power, monitoring for safety and futility, and monitoring
multiple endpoints in the study. The use of monitoring clinical trials is introduced
in the context of the evolution of clinical research, and one chapter is devoted to
the more recent Bayesian procedures.
Dr. Lemuel
University of Texas School of Public Health. He is a diplomat of the National Board
of Medical Examiners and is currently Professor of Biostatistics at the University
of Texas School of Public Health in Houston where he holds a full time faculty
position.
Dr. Move has carried out cardiovascular research for twenty years and continues to
be involved in the design, execution and analysis of clinical trials, both reporting
to and serving on many Data Monitoring Committees. He has served in several
clinical trials sponsored by both the U.S. government and private industry. In addi¬
tion. Dr. Move has served as statistician/epidemiologist for six years on both the
Cardiovascular and Renal Drug Advisory Committee to the Food and Drug
Administration and the Pharmacy Sciences Advisory Committee to the FDA.
He has published over
design, execution and analysis of clinical research. He authored Statistical
Reasoning in Medicine: The Intuitive P-value Primer (Springer,
Analysis in Clinical Trials: Fundamentals for Investigators (Springer,
|
| adam_txt |
Contents
Preface
Acknowledgments
Contents
Introduction
1.
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8
1.9
1.10
1.11
1.12
1.13
1.14
1.15
1.16
1.17
1.18
1.19
References
2.
2.1
2.2
2.2.1
2.3
2.3.1
2.4
2.5
2.5.1
2.5.2
2.5.3
2.5.4
xiii
Table of
2.6
2.7
2.7.1
2.7.2
2.7.2.1
2.7.2.2
2.7.3
2.7.4
2.7.5
2.8
References
3.
3.1
3.2
3.3
3.4
3.4.1
3.4.2
3.4.3
3.4.4
3.4.5
3.4.6
3.4.7
3.4.8
3.5
3.5.1
3.5.2
3.6
3.6.1
3.6.2
3.6.2.1
3.6.2.2
3.7
Problems
References
4.
4.1
4.2
4.3.
4.3.1
4.3.2
4.3.3
4.4
4.4.1
4.4.2
4.4.3
4.4.4
Table of
4.4.5
4.4.6
4.4.7
4.5
4.5.1.
4.5.1.1
4.5.1.2
4.5.1.3
4.5.2
4.5.3
4.5.4
4.6
Problems
References
5.
5.1
5.2
5.3
5.4
5.4.1
5.4.2
5.5
5.6
5.6.1
5.6.2
5.6.3
5.7
5.7.1
5.7.1.1
5.7.2
Problems
References
6.
6.1
6.2
6.3
6.4.
6.5
6.6
6.7
6.7.1
6.8
6.9
Problems
References
Table of
7.
7.1
7.2
7.3
7.3.1
7.3.2
7.3.3
7.3.4
7.4
7.5
7.5.1
7.5.2
7.5.3
7.5.4
7.6
7.6.1
7.6.2
7.6.3
Problems
References
8.
8.1
8.2
8.2.1
8.2.2
8.2.3
8.3
8.4
8.5
Problems
References
Appendix A. Boundary Values for Normal Mean
Appendix B. Conditional Brownian Motion
B.I Nomenclature and Background Mathematics
B.I.I Notation
B.1.2Multivariate Normal Distributions
B.2 Covariance and Brownian Motion Elements
B.3 Brownian Motion Conditioned on the Past
B.4 Brownian Motion Conditioned on the Past and Future
Appendix C. Boundary Values and Conditional Power
C.I Monitoring for Efficacy or Harm
C.2 Calculation for Futility
Appendix D. Supporting Bayesian Computations
xvii Table of Contents
D.I.
Appendix E. Standard Normal Probabilities
Index
Statistical Monitoring of Clinical Trials: Fundamentals for Investigators intro¬
duces the investigator and statistician to monitoring procedures in clinical
research. Clearly presenting the necessary background with limited use of mathe¬
matics, this book increases the knowledge, experience, and intuition of investiga¬
tions in the use of these important procedures now required by the many clinical
research efforts.
The author provides motivated clinical investigators the background, correct use,
and interpretation of these monitoring procedures at an elementary statistical
level. He defines terms commonly used such as group sequential procedures and
stochastic curtailment in non-mathematical language and discusses the common¬
ly used procedures of Pocock, O'Brien-Fleming, and Lan-DeMets. He discusses the
notions of conditional power, monitoring for safety and futility, and monitoring
multiple endpoints in the study. The use of monitoring clinical trials is introduced
in the context of the evolution of clinical research, and one chapter is devoted to
the more recent Bayesian procedures.
Dr. Lemuel
University of Texas School of Public Health. He is a diplomat of the National Board
of Medical Examiners and is currently Professor of Biostatistics at the University
of Texas School of Public Health in Houston where he holds a full time faculty
position.
Dr. Move has carried out cardiovascular research for twenty years and continues to
be involved in the design, execution and analysis of clinical trials, both reporting
to and serving on many Data Monitoring Committees. He has served in several
clinical trials sponsored by both the U.S. government and private industry. In addi¬
tion. Dr. Move has served as statistician/epidemiologist for six years on both the
Cardiovascular and Renal Drug Advisory Committee to the Food and Drug
Administration and the Pharmacy Sciences Advisory Committee to the FDA.
He has published over
design, execution and analysis of clinical research. He authored Statistical
Reasoning in Medicine: The Intuitive P-value Primer (Springer,
Analysis in Clinical Trials: Fundamentals for Investigators (Springer, |
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| id | DE-604.BV021573087 |
| illustrated | Illustrated |
| index_date | 2024-07-02T14:39:06Z |
| indexdate | 2024-07-09T20:38:57Z |
| institution | BVB |
| isbn | 0387277811 9780387277813 |
| language | English |
| lccn | 2005931408 |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-014788867 |
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| physical | XXI, 254 S. graph. Darst. |
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| spelling | Moyé, Lemuel A. 1952- Verfasser (DE-588)122260651 aut Statistical monitoring of clinical trials fundamentals for investigators Lemuel A. Moyé New York, NY Springer 2006 XXI, 254 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Includes bibliographical references and index Études cliniques - Méthodes statistiques Clinical trials Statistical methods Clinical Trials statistics & numerical data Data Interpretation, Statistical Klinische Prüfung (DE-588)4031192-2 gnd rswk-swf Datenanalyse (DE-588)4123037-1 gnd rswk-swf Klinische Prüfung (DE-588)4031192-2 s Datenanalyse (DE-588)4123037-1 s DE-604 Digitalisierung UB Regensburg application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014788867&sequence=000003&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Klappentext Digitalisierung UBRegensburg application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014788867&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Moyé, Lemuel A. 1952- Statistical monitoring of clinical trials fundamentals for investigators Études cliniques - Méthodes statistiques Clinical trials Statistical methods Clinical Trials statistics & numerical data Data Interpretation, Statistical Klinische Prüfung (DE-588)4031192-2 gnd Datenanalyse (DE-588)4123037-1 gnd |
| subject_GND | (DE-588)4031192-2 (DE-588)4123037-1 |
| title | Statistical monitoring of clinical trials fundamentals for investigators |
| title_auth | Statistical monitoring of clinical trials fundamentals for investigators |
| title_exact_search | Statistical monitoring of clinical trials fundamentals for investigators |
| title_exact_search_txtP | Statistical monitoring of clinical trials fundamentals for investigators |
| title_full | Statistical monitoring of clinical trials fundamentals for investigators Lemuel A. Moyé |
| title_fullStr | Statistical monitoring of clinical trials fundamentals for investigators Lemuel A. Moyé |
| title_full_unstemmed | Statistical monitoring of clinical trials fundamentals for investigators Lemuel A. Moyé |
| title_short | Statistical monitoring of clinical trials |
| title_sort | statistical monitoring of clinical trials fundamentals for investigators |
| title_sub | fundamentals for investigators |
| topic | Études cliniques - Méthodes statistiques Clinical trials Statistical methods Clinical Trials statistics & numerical data Data Interpretation, Statistical Klinische Prüfung (DE-588)4031192-2 gnd Datenanalyse (DE-588)4123037-1 gnd |
| topic_facet | Études cliniques - Méthodes statistiques Clinical trials Statistical methods Clinical Trials statistics & numerical data Data Interpretation, Statistical Klinische Prüfung Datenanalyse |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014788867&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=014788867&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT moyelemuela statisticalmonitoringofclinicaltrialsfundamentalsforinvestigators |