Name penned on first blank page, and that page also has a wrinkled corner. Rest of text is in excellent condition - crisp, clean and unmarked. Cover is glossy with mild surface and edge wear; light bend across back bottom edge. Binding is tight and square; no creases to spine. Light sun fading on and around spine. We are unable to ship oversize books and multi-volume sets internationally.

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Detalles bibliogr�ficos

T�tulo

Data Monitoring in Clinical Trials: A Case Studies Approach

Editor

Springer

Fecha de publicaci�n

2006

Idioma

Ingl�s

ISBN 10

0387203303

ISBN 13

9780387203300

Encuadernaci�n

paperback

Estado

Very Good +

Estado de la sobrecubierta

None as issued

Peso

20 onzas

Cat�logos de vendedores

Medicine

Acerca de

Sinopsis

During the past three decades, clinical trials have evolved to become major research methodology for clinical medicine. Many statistical principles have been applied to the design, conduct, and anlysis of clinical trials, and these statistical methodologies continue to evolve as we apply clinical trials to an increasing array of research settings.

De la contraportada

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 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 studies to go along with cases contributed by a distinguished group of colleagues experienced in the design, monitoring and analysis of clinical trials. Dr. David DeMets is currently Professor and 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 Biometric Society, a past member of the Board of Directors 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 significant contributions to the field of clinical trials. Dr. Curt 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 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 of Clinical Trials. The editors have collaborated previously as coauthors of a text: the Fundamentals of Clinical Trials.

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An online bookseller since 2003, we seek out unusual, scarce, and specialty books, while maintaining a broad selection of general interest titles. Our descriptions attempt to provide a good overall view of each book's condition, but we are always available to answer specific questions and are usually able to do so within 48 hours. When shipped, all books are placed in sealed, archival-quality plastic sleeves (unless already sealed with publisher's shrink wrap), then placed in a new box with bubble wrap. You can be confident your order will arrive in excellent condition. We use the US Postal Service for shipping, so please provide your MAILING address on your order. Thank you for considering our offers. We look forward to serving you.

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Lake Country Books and More
MN, U.S.A.

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