Data monitoring in clinical trials: a case studies approach
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
New York, NY
Springer
2006
|
| Subjects: | |
| Online Access: | Inhaltsverzeichnis Klappentext |
| Physical Description: | XXVI, 374 S. graph. Darst. |
| ISBN: | 0387203303 9780387203300 |
Staff View
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| 245 | 1 | 0 | |a Data monitoring in clinical trials |b a case studies approach |c David L. DeMets ... eds. |
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| adam_text | Contents
Preface v
Contributors ix
Section
1
David L.
Curt D. Furberg
Lawrence M. Friedman
2
David L.
Curt D. Furberg
Lawrence M. Friedman
3
Susan S.
Jay
Section
Introduction to Case Studies Showing
Benefit From the Intervention
David L
Curt D. Furberg
Lawrence M. Friedman
Case
Early: The Diabetic Retinopathy Study
Experience
Fred Ederer
Case
Blocker Heart Attack TriaL Early Experience
in Formal Monitoring Methods
Lawrence M. Friedman
David L
Robert Hardy
xxi
xxii Contents
Case
of the Physicians Health Study: Issues in Early
Termination for a Major Secondary
David L.
Charles H.
Case
in Atrial Fibrillation I Trial: Protecting
Participant Interests in the Face of Scientific
Uncertainties and the Cruel Play of Chance
Robert G. Hart
LeslyA. Pear
Ruth McBride
Richard A. Kronmal
Case
and Complications Trial
John M. Lachin
Patricia Cleary
Oscar Crqfford
Saul Genuth
David Nathan
Charles Clark
Frederick Ferris
Carolyn Siebert
for the DCCT Research Group
Case
Group Study
Dianne M. Finkelstein
Case
Prevention Trial
Carol K. Redmond
Joseph P. Costantino
Theodore Cotton
Case
CB/XL Randomized Intervention Trial in
Chronic Heart Failure: Potentially High-Risk
Treatment in High-Risk Patients
Jan Feyzi
Desmond Julian
John Wikstrand
Hans
Contents xxiii
Case
Evaluation Study Early for Efficacy
Janet
Jean-Pierre Boissel
Curt D. Furberg
Desmond Julian
Henri Kulbertus
Stuart Pocock
Case
Prevention Evaluation and the Clopidogrel
in Unstable Angina to Prevent Recurrent
Ischemie
Information Loss
Janice Pogue
David Sackett
DGWyse
Salim Yusuf
Case
Candesartan in Heart Failure Assessment of
Reduction in Mortality and Morbidity Program
Stuart Pocock
Duolao Wang
Lars Wilbelmsen
Charles H.
Section
Introduction to Case Studies Showing
Harmful Effects of the Intervention
David L
Curt D. Furberg
Lawrence M. Friedman
Case
the Coronary Drug Project
Paul
Case
Arrhythmia Suppression Trial: The Need To Be
Prepared Early
David L
Lawrence M. Friedman
xxiv Contents
Case
Randomized Milrinone Survival
Dealing with an Agonizing Trend
Susan Anderson
Robert Cody
Milton Packer
Richard
Case
Trial: The Viewpoint of the Safety and
Endpoint
Anthony B. Miller
Julie Buring
O. Dale Williams
Case
Informed Consent: Diaspirin Cross-linked
Hemoglobin for Emergency Treatment of
Post-Traumatic Shock
Roger J. Lewis
Norman Fost
Case
Challenges in Monitoring the Heart and
Estrogen/Progestin Replacement Study
Stephen B. Hulley
Deborah Grady
Eric Vittinghoff
O. Dale Williams
Case
and Iipid-Lowering Treatment to Prevent
Heart Attack Trial: Early Termination of
the Doxazosin Treatment Arm
Barry R. Davis
Jeffrey A. Cutler
Case
Congestive Heart Failure Trial
Stuart Pocock
Lars Wilhelmsen
Kenneth
Gary Francis
Janet
Contents xxv
Case
Trial of Daclizuniab in Acute Graft-
Versus-Host Disease
David Zahrieh
Stephanie J. Lee
David Harrington
Section
Introduction to Case Studies With Special Issues
David L.
Curt D. Furberg
Lawrence M. Friedman
Case
The Role of the Data Monitoring Committee
Richard J.Whitley
Case
Monitoring Experience: Problem With
Reporting Lags
David L
George W Williams
Byron W. Brown, Jr.
Case
New Scandinavian Enalapril Survival Study II
Steven Snapinn
Curt D. Furberg
Case
Fibrillation: Missing the Window of
Opportunity
Charles H.
Curt D. Furberg
Case
Toxoplasmic
James D. Neaton
Deborah N.Wentworth
Mark AJacobson
xxvi Contents
Case
of Strategies for Left Ventricular Dysfunction
Pilot Study: When Reasonable People Disagree
Janice Pogue
Salim Yusuf
Case
Post-Infarct Survival Control in Left
Ventricular Dysfunction Study: Hazards of
Changing Primary Outcomes
Desmond Julian
Case
Clinical Trial in Early Breast Cancer
Stephen L. George
Mark R. Green
Case
Bevaclzumab Colorectal Cancer Clinical Trial
Janet
Eric Holmgren
Heidi Christ-Schmidt
Alex Bajamonde
Appendix
Appendix
Index
Randomized clinical trials are the gold standard for establishing many clinical practice
guidelines and are central to evidence based medicine. Obtaining the best evidence
through clinical trials must be done within the boundaries of rigorous science and eth¬
ical principles. One fundamental principle is that trials should not continue longer than
necessary to reach their objectives. Therefore, trials must be monitored for recruitment
progress, quality of data, adherence to patient care or prevention standards, and early
evidence of benefit or harm. Frequently, a group of external experts, independent from
the investigators and trial sponsor, is charged with this monitoring responsibility, espe¬
cially for safety and early benefit. This group is referred to by various names, such as a
data monitoring committee or a data and safety monitoring board. This book, through
a series of case studies presented by many distinguished clinical trial experts, illustrates
the complexity of this monitoring process. The editors provide an overview of the
process and a summary of a multitude of the lessons learned from the cases presented.
This book should be useful to anyone serving on a data and safety monitoring board,
or planning to do so, for colleagues in
and for students in biostatistics, epidemiology, clinical trials and medical ethics. No
other text has as extensive a collection of cases which provide insight into the many
issues, often conflicting, that must be examined before recommendations to continue
or discontinue a trial can be made. While depth in statistical methods is not required,
some familiarity with statistical design and analysis issues in clinical trials is helpful.
The cases cover trials which were terminated early for convincing evidence of benefit,
or for harmful effects and trials that continue to their scheduled ends. Cases with com¬
plex issues are also included. This series of cases should provide broad background
information for potential monitoring committee members and better prepare them for
the challenges that may exist in the trials for which they are responsible.
The three editors have contributed two overview chapters as well as several case stud¬
ies to go along with cases contributed by colleagues experienced in the design, moni¬
toring and analysis of clinical trials. Dr. David L.
Chair, Department of Biostatistics and Medical Informatics at the University of
Wisconsin-Madison. He is past president of the Eastern North American Region
(ENAR) of the International
of the American Statistical Association and an elected Fellow. He recently received the
Robert Gordon Lectureship Award, given by the National Institutes of Health, for sig¬
nificant contributions to the field of clinical trials. Dr. Curt D. Furberg, is currently
Professor (and former Chair) of the Department of Public Health Sciences at Wake
Forest University. Previously, he was Head of the Clinical Trials Branch and Associate
Director of the Clinical Applications and Prevention Program at the National Heart,
Lung, and Blood Institute. Dr. Lawrence M. Friedman is a former Director of the
Division of Epidemiology and Clinical Applications and a former Assistant Director for
Ethics and Clinical Research at the National Heart, Lung, and Blood Institute. All three
are past presidents of the Society for Clinical Trials. The editors have collaborated pre¬
viously as coauthors of The Fundamentals of Clinical Trials.
|
| adam_txt |
Contents
Preface v
Contributors ix
Section
1
David L.
Curt D. Furberg
Lawrence M. Friedman
2
David L.
Curt D. Furberg
Lawrence M. Friedman
3
Susan S.
Jay
Section
Introduction to Case Studies Showing
Benefit From the Intervention
David L
Curt D. Furberg
Lawrence M. Friedman
Case
Early: The Diabetic Retinopathy Study
Experience
Fred Ederer
Case
Blocker Heart Attack TriaL Early Experience
in Formal Monitoring Methods
Lawrence M. Friedman
David L
Robert Hardy
xxi
xxii Contents
Case
of the Physicians' Health Study: Issues in Early
Termination for a Major Secondary
David L.
Charles H.
Case
in Atrial Fibrillation I Trial: Protecting
Participant Interests in the Face of Scientific
Uncertainties and the Cruel Play of Chance
Robert G. Hart
LeslyA. Pear
Ruth McBride
Richard A. Kronmal
Case
and Complications Trial
John M. Lachin
Patricia Cleary
Oscar Crqfford
Saul Genuth
David Nathan
Charles Clark
Frederick Ferris
Carolyn Siebert
for the DCCT Research Group
Case
Group Study
Dianne M. Finkelstein
Case
Prevention Trial
Carol K. Redmond
Joseph P. Costantino
Theodore Cotton
Case
CB/XL Randomized Intervention Trial in
Chronic Heart Failure: Potentially High-Risk
Treatment in High-Risk Patients
Jan Feyzi
Desmond Julian
John Wikstrand
Hans
Contents xxiii
Case
Evaluation Study Early for Efficacy
Janet
Jean-Pierre Boissel
Curt D. Furberg
Desmond Julian
Henri Kulbertus
Stuart Pocock
Case
Prevention Evaluation and the Clopidogrel
in Unstable Angina to Prevent Recurrent
Ischemie
Information Loss
Janice Pogue
David Sackett
DGWyse
Salim Yusuf
Case
Candesartan in Heart Failure Assessment of
Reduction in Mortality and Morbidity Program
Stuart Pocock
Duolao Wang
Lars Wilbelmsen
Charles H.
Section
Introduction to Case Studies Showing
Harmful Effects of the Intervention
David L
Curt D. Furberg
Lawrence M. Friedman
Case
the Coronary Drug Project
Paul
Case
Arrhythmia Suppression Trial: The Need To Be
Prepared Early
David L
Lawrence M. Friedman
xxiv Contents
Case
Randomized Milrinone Survival
Dealing with an Agonizing Trend
Susan Anderson
Robert Cody
Milton Packer
Richard
Case
Trial: The Viewpoint of the Safety and
Endpoint
Anthony B. Miller
Julie Buring
O. Dale Williams
Case
Informed Consent: Diaspirin Cross-linked
Hemoglobin for Emergency Treatment of
Post-Traumatic Shock
Roger J. Lewis
Norman Fost
Case
Challenges in Monitoring the Heart and
Estrogen/Progestin Replacement Study
Stephen B. Hulley
Deborah Grady
Eric Vittinghoff
O. Dale Williams
Case
and Iipid-Lowering Treatment to Prevent
Heart Attack Trial: Early Termination of
the Doxazosin Treatment Arm
Barry R. Davis
Jeffrey A. Cutler
Case
Congestive Heart Failure Trial
Stuart Pocock
Lars Wilhelmsen
Kenneth
Gary Francis
Janet
Contents xxv
Case
Trial of Daclizuniab in Acute Graft-
Versus-Host Disease
David Zahrieh
Stephanie J. Lee
David Harrington
Section
Introduction to Case Studies With Special Issues
David L.
Curt D. Furberg
Lawrence M. Friedman
Case
The Role of the Data Monitoring Committee
Richard J.Whitley
Case
Monitoring Experience: Problem With
Reporting Lags
David L
George W Williams
Byron W. Brown, Jr.
Case
New Scandinavian Enalapril Survival Study II
Steven Snapinn
Curt D. Furberg
Case
Fibrillation: Missing the Window of
Opportunity
Charles H.
Curt D. Furberg
Case
Toxoplasmic
James D. Neaton
Deborah N.Wentworth
Mark AJacobson
xxvi Contents
Case
of Strategies for Left Ventricular Dysfunction
Pilot Study: When Reasonable People Disagree
Janice Pogue
Salim Yusuf
Case
Post-Infarct Survival Control in Left
Ventricular Dysfunction Study: Hazards of
Changing Primary Outcomes
Desmond Julian
Case
Clinical Trial in Early Breast Cancer
Stephen L. George
Mark R. Green
Case
Bevaclzumab Colorectal Cancer Clinical Trial
Janet
Eric Holmgren
Heidi Christ-Schmidt
Alex Bajamonde
Appendix
Appendix
Index
Randomized clinical trials are the gold standard for establishing many clinical practice
guidelines and are central to evidence based medicine. Obtaining the best evidence
through clinical trials must be done within the boundaries of rigorous science and eth¬
ical principles. One fundamental principle is that trials should not continue longer than
necessary to reach their objectives. Therefore, trials must be monitored for recruitment
progress, quality of data, adherence to patient care or prevention standards, and early
evidence of benefit or harm. Frequently, a group of external experts, independent from
the investigators and trial sponsor, is charged with this monitoring responsibility, espe¬
cially for safety and early benefit. This group is referred to by various names, such as a
data monitoring committee or a data and safety monitoring board. This book, through
a series of case studies presented by many distinguished clinical trial experts, illustrates
the complexity of this monitoring process. The editors provide an overview of the
process and a summary of a multitude of the lessons learned from the cases presented.
This book should be useful to anyone serving on a data and safety monitoring board,
or planning to do so, for colleagues in
and for students in biostatistics, epidemiology, clinical trials and medical ethics. No
other text has as extensive a collection of cases which provide insight into the many
issues, often conflicting, that must be examined before recommendations to continue
or discontinue a trial can be made. While depth in statistical methods is not required,
some familiarity with statistical design and analysis issues in clinical trials is helpful.
The cases cover trials which were terminated early for convincing evidence of benefit,
or for harmful effects and trials that continue to their scheduled ends. Cases with com¬
plex issues are also included. This series of cases should provide broad background
information for potential monitoring committee members and better prepare them for
the challenges that may exist in the trials for which they are responsible.
The three editors have contributed two overview chapters as well as several case stud¬
ies to go along with cases contributed by colleagues experienced in the design, moni¬
toring and analysis of clinical trials. Dr. David L.
Chair, Department of Biostatistics and Medical Informatics at the University of
Wisconsin-Madison. He is past president of the Eastern North American Region
(ENAR) of the International
of the American Statistical Association and an elected Fellow. He recently received the
Robert Gordon Lectureship Award, given by the National Institutes of Health, for sig¬
nificant contributions to the field of clinical trials. Dr. Curt D. Furberg, is currently
Professor (and former Chair) of the Department of Public Health Sciences at Wake
Forest University. Previously, he was Head of the Clinical Trials Branch and Associate
Director of the Clinical Applications and Prevention Program at the National Heart,
Lung, and Blood Institute. Dr. Lawrence M. Friedman is a former Director of the
Division of Epidemiology and Clinical Applications and a former Assistant Director for
Ethics and Clinical Research at the National Heart, Lung, and Blood Institute. All three
are past presidents of the Society for Clinical Trials. The editors have collaborated pre¬
viously as coauthors of The Fundamentals of Clinical Trials. |
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| spelling | Data monitoring in clinical trials a case studies approach David L. DeMets ... eds. New York, NY Springer 2006 XXVI, 374 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Datenverarbeitung Clinical trials Data processing Clinical trials Case studies (DE-588)4522595-3 Fallstudiensammlung gnd-content DeMets, David L. 1944- Sonstige (DE-588)120551373 oth Digitalisierung UBRegensburg application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014811828&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=014811828&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Klappentext |
| spellingShingle | Data monitoring in clinical trials a case studies approach Datenverarbeitung Clinical trials Data processing Clinical trials Case studies |
| subject_GND | (DE-588)4522595-3 |
| title | Data monitoring in clinical trials a case studies approach |
| title_auth | Data monitoring in clinical trials a case studies approach |
| title_exact_search | Data monitoring in clinical trials a case studies approach |
| title_exact_search_txtP | Data monitoring in clinical trials a case studies approach |
| title_full | Data monitoring in clinical trials a case studies approach David L. DeMets ... eds. |
| title_fullStr | Data monitoring in clinical trials a case studies approach David L. DeMets ... eds. |
| title_full_unstemmed | Data monitoring in clinical trials a case studies approach David L. DeMets ... eds. |
| title_short | Data monitoring in clinical trials |
| title_sort | data monitoring in clinical trials a case studies approach |
| title_sub | a case studies approach |
| topic | Datenverarbeitung Clinical trials Data processing Clinical trials Case studies |
| topic_facet | Datenverarbeitung Clinical trials Data processing Clinical trials Case studies Fallstudiensammlung |
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