Data Monitoring Committees in Clinical Trials

Idioma: inglés

Editorial: John Wiley and Sons Inc, US, 2019

1119512654 / 9781119512653

Serie: Libro 40 de 49 - Statistics in Practice

Librería: Rarewaves.com USA, London, London, Reino UnidoRarewaves.com USA

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­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.…

N° de ref. del artículo LU-9781119512653

Título
Data Monitoring Committees in Clinical Trials
Autor
Thomas R. Fleming, David L. DeMets, Susan S. Ellenberg
Editorial
John Wiley and Sons Inc, US
Año de publicación
2019
Estado
New
Encuadernación
Hardback
Idioma
inglés
ISBN 10
1119512654
ISBN 13
9781119512653
Edición
2ª Edición
Peso del artículo
700 gramos
Serie
Libro 40 de 49: Statistics in Practice

Rarewaves.com USA

London, London, Reino Unido

Vendedor de 5 estrellas

Vendedor de IberLibro desde 11 de junio de 2025

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