David L. DeMets – författare

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13 produkter

Fundamentals of Clinical Trials
AvLawrence M. Friedman,Curt D. Furbergm. fl.
Häftad, Engelska, 2015
5,0 utav 5 stjärnor. Totalt antal röster:(2)
635 kr
Skickas inom 10-15 vardagar
This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing and international trials.This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examplesof published clinical trials to illustrate the fundamentals.The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and reporting the trial results according to the pre-specified objectives.Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to aminimum, the statistician may still find the principles and fundamentals presented in this text useful.
Data Monitoring in Clinical Trials
A Case Studies Approach
AvDavid L. DeMets,Curt D. Furbergm. fl.
Häftad, Engelska, 2005
973 kr
Skickas inom 10-15 vardagar
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 ethical 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, especially 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 academia, industry and governmental agencies, and for teaching 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. Cases with complex issues are also included. This series of cases should provide broad background information for potentialmonitoring committee members and better prepare them for the challenges that may exist in the trials for which they are responsible. "This book is a must-read for individuals serving on or supporting data monitoring committees as well as statisticians and other disciplines involved in the design and analysis of clinical trials with interim monitoring." Journal of Biopharmaceutical Sciences, Issue 6, 2006
Data Monitoring in Clinical Trials
A Case Studies Approach
AvLawrence M. Friedman,Curt D. Furbergm. fl.
E-bok
PDF, Engelska, 2006
1 176 kr
Läs direkt efter köp
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 ethical 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, especially 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 academia, industry and governmental agencies, and for teaching 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. Cases with complex issues are also included. This series of cases should provide broad background information for potentialmonitoring committee members and better prepare them for the challenges that may exist in the trials for which they are responsible.
"This book is a must-read for individuals serving on or supporting data monitoring committees as well as statisticians and other disciplines involved in the design and analysis of clinical trials with interim monitoring." Journal of Biopharmaceutical Sciences, Issue 6, 2006
Data Monitoring Committees in Clinical Trials
A Practical Perspective
AvDavid L. DeMets,Thomas R. Flemingm. fl.
E-bok
PDF, Engelska, 2003
1 618 kr
Läs direkt efter köp
There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities.
Provides a practical overview of data monitoring in clinical trials. Describes the purpose, responsibilities and operation of data monitoring committees. Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees. Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees. Discusses issues pertinent to those working in clinical trials in both the US and Europe.
The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.
Introduction to Statistical Methods for Clinical Trials
AvDavid L. DeMets,Thomas D. Cook
E-bok
Engelska, 2007
1 636 kr
Läs direkt efter köp
This text provides a solid understanding of the various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. It covers basic experimental design, sample size, randomization procedures, interim and survival analyses, quality of life assessment, and longitudinal methods. The book describes all phases of a clinical trial and explores the advantages of and objections to the intent-to-treat principle as well as its implementation. With exercises at the end of most chapters, it also illustrates methods using examples with real data from a variety of disease areas, including heart and lung diseases, cancer, and AIDS.
Data Monitoring Committees in Clinical Trials
A Practical Perspective
AvDavid L. DeMets,Thomas R. Flemingm. fl.
E-bok
PDF, Engelska, 2019
1 576 kr
Läs direkt efter köp
The authoritative guide for Data Monitoring Committees—fully revised and updated

The number of clinical trials sponsored by government agencies and pharmaceutical companies has grown in recent years, prompting an increased need for interim monitoring of data on safety and efficacy. Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and protecting the credibility and validity of the study. Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition offers practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees, providing a practical overview of the establishment, purpose, and responsibilities of these committees.

Examination of topics such as the composition and independence of DMCs, statistical, philosophical and ethical considerations, and determining when a DMC is needed, presents readers with a comprehensive foundational knowledge of clinical trial oversight.

Providing recent examples to illustrate DMC principles, this fully-updated guide reflects current developments and practices in clinical trial oversight and offers expanded coverage of emerging issues and challenges in the field. This new second edition covers the most current information on DMC policies, issues in monitoring trials using new designs, and recent trial publications relevant to DMC decision-making.

• Presents practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees

• Illustrates the types of challenging issues Data Monitoring Committees face in practical situations

• Provides updated and expanded coverage of topics including regulatory and funding agency guidelines and trial designs and their associated demands and limitations

• Includes a new chapter addressing legal issues that affect DMC members and discusses general litigation concerns relevant to clinical research

• Expands treatment of current journal publications addressing DMC issues

Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition is a must-have text for anyone engaged in DMC activities as well as trial sponsors, clinical trial researchers, regulatory and bioethics professionals, and those associated with clinical trials in academic, government and industry settings.
Data Monitoring Committees in Clinical Trials
A Practical Perspective
AvSusan S. Ellenberg,Thomas R. Flemingm. fl.
Inbunden, Engelska, 2019
1 351 kr
Skickas inom 5-8 vardagar
The authoritative guide for Data Monitoring Committees—fully revised and updatedThe number of clinical trials sponsored by government agencies and pharmaceutical companies has grown in recent years, prompting an increased need for interim monitoring of data on safety and efficacy. Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and protecting the credibility and validity of the study. Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition offers practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees, providing a practical overview of the establishment, purpose, and responsibilities of these committees.Examination of topics such as the composition and independence of DMCs, statistical, philosophical and ethical considerations, and determining when a DMC is needed, presents readers with a comprehensive foundational knowledge of clinical trial oversight.Providing recent examples to illustrate DMC principles, this fully-updated guide reflects current developments and practices in clinical trial oversight and offers expanded coverage of emerging issues and challenges in the field. This new second edition covers the most current information on DMC policies, issues in monitoring trials using new designs, and recent trial publications relevant to DMC decision-making.• Presents practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees• Illustrates the types of challenging issues Data Monitoring Committees face in practical situations• Provides updated and expanded coverage of topics including regulatory and funding agency guidelines and trial designs and their associated demands and limitations• Includes a new chapter addressing legal issues that affect DMC members and discusses general litigation concerns relevant to clinical research• Expands treatment of current journal publications addressing DMC issuesData Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition is a must-have text for anyone engaged in DMC activities as well as trial sponsors, clinical trial researchers, regulatory and bioethics professionals, and those associated with clinical trials in academic, government and industry settings.
Data Monitoring Committees in Clinical Trials
A Practical Perspective
AvDavid L. DeMets,Thomas R. Flemingm. fl.
E-bok
Engelska, 2019
1 576 kr
Läs direkt efter köp
The authoritative guide for Data Monitoring Committees—fully revised and updated

The number of clinical trials sponsored by government agencies and pharmaceutical companies has grown in recent years, prompting an increased need for interim monitoring of data on safety and efficacy. Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and protecting the credibility and validity of the study. Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition offers practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees, providing a practical overview of the establishment, purpose, and responsibilities of these committees.

Examination of topics such as the composition and independence of DMCs, statistical, philosophical and ethical considerations, and determining when a DMC is needed, presents readers with a comprehensive foundational knowledge of clinical trial oversight.

Providing recent examples to illustrate DMC principles, this fully-updated guide reflects current developments and practices in clinical trial oversight and offers expanded coverage of emerging issues and challenges in the field. This new second edition covers the most current information on DMC policies, issues in monitoring trials using new designs, and recent trial publications relevant to DMC decision-making.

• Presents practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees

• Illustrates the types of challenging issues Data Monitoring Committees face in practical situations

• Provides updated and expanded coverage of topics including regulatory and funding agency guidelines and trial designs and their associated demands and limitations

• Includes a new chapter addressing legal issues that affect DMC members and discusses general litigation concerns relevant to clinical research

• Expands treatment of current journal publications addressing DMC issues

Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition is a must-have text for anyone engaged in DMC activities as well as trial sponsors, clinical trial researchers, regulatory and bioethics professionals, and those associated with clinical trials in academic, government and industry settings.
Introduction to Statistical Methods for Clinical Trials
AvDavid L. DeMets,Thomas D. Cook
E-bok
PDF, Engelska, 2007
1 636 kr
Läs direkt efter köp
This text provides a solid understanding of the various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. It covers basic experimental design, sample size, randomization procedures, interim and survival analyses, quality of life assessment, and longitudinal methods. The book describes all phases of a clinical trial and explores the advantages of and objections to the intent-to-treat principle as well as its implementation. With exercises at the end of most chapters, it also illustrates methods using examples with real data from a variety of disease areas, including heart and lung diseases, cancer, and AIDS.
Fundamentals of Clinical Trials
AvDavid L. DeMets,Curt D. Furbergm. fl.
E-bok
PDF, Engelska, 2010
780 kr
Läs direkt efter köp
The clinical trial is “the most definitive tool for evaluation of the applicability of clinical research.” It represents “a key research activity with the potential to improve the quality of health care and control costs through careful comparison of alternative treatments” [1]. It has been called on many occasions, “the gold st- dard” against which all other clinical research is measured. Although many clinical trials are of high quality, a careful reader of the medical literature will notice that a large number have deficiencies in design, conduct, analysis, presentation, and/or interpretation of results. Improvements have occurred over the past few decades, but too many trials are still conducted without adequate attention to its fundamental principles. Certainly, numerous studies could have been upgraded if the authors had had a better understanding of the fundamentals. Since the publication of the first edition of this book, a large number of other texts on clinical trials have appeared, most of which are indicated here [2–21]. Several of them, however, discuss only specific issues involved in clinical trials. Additionally, many are no longer current. The purpose of this fourth edition is to update areas in which major progress has been made since the publication of the third edition. We have revised most chapters considerably and added one on ethical issues.
Introduction to Statistical Methods for Clinical Trials
AvThomas D. Cook,David L. DeMets
Inbunden, Engelska, 2007
1 532 kr
Skickas inom 10-15 vardagar
Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial.After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials.
Fundamentals of Clinical Trials
AvLawrence M. Friedman,Curt D. Furbergm. fl.
Inbunden, Engelska, 2015
4,0 utav 5 stjärnor. Totalt antal röster:(1)
901 kr
Skickas inom 10-15 vardagar
This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing and international trials.This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examplesof published clinical trials to illustrate the fundamentals.The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and reporting the trial results according to the pre-specified objectives.Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to aminimum, the statistician may still find the principles and fundamentals presented in this text useful.
Fundamentals of Clinical Trials
AvChristopher B. Granger,David M. Reboussinm. fl.
E-bok
Engelska, 2015
732 kr
Läs direkt efter köp
This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing and international trials.
This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examplesof published clinical trials to illustrate the fundamentals.
The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and reporting the trial results according to the pre-specified objectives.
Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to aminimum, the statistician may still find the principles and fundamentals presented in this text useful.

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David L. DeMets – författare

Fundamentals of Clinical Trials

Data Monitoring in Clinical Trials

Data Monitoring in Clinical Trials

Data Monitoring Committees in Clinical Trials

Introduction to Statistical Methods for Clinical Trials

Data Monitoring Committees in Clinical Trials

Data Monitoring Committees in Clinical Trials

Data Monitoring Committees in Clinical Trials

Introduction to Statistical Methods for Clinical Trials

Fundamentals of Clinical Trials

Introduction to Statistical Methods for Clinical Trials

Fundamentals of Clinical Trials

Fundamentals of Clinical Trials

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