­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 in Clinical Trial: A Practical Perspective ist die erweiterte 2. Auflage des weit verbreiteten und viel beachteten Fachbuchs, das erstmals im Jahr 2002 erschienen ist. Es bietet einen fundierten und aktuellen Überblick über Datenkontrollkomitees, deren Einrichtung, Zweck und Zuständigkeiten.

- Enthält direkt umsetzbare Handreichungen für alle, die klinische Studien verwalten und durchführen, sowie für Mitglieder von Datenkontrollkomitees.
- Liefert Mitgliedern von Behörden- und Ethikkommissionen Einblicke in die Kontrolle klinischer Daten.
- Diskutiert Themen mit Relevanz für diejenigen, die in den USA und in Europa an klinischen Studien arbeiten.

Die praktischen Handlungsansätze in diesem Buch sind für Experten aus dem akademischen Bereich, bei Regierungsstellen und aus der Industrie, vor allem für Medizinstatistiker, Kliniker, Koordinatoren von klinischen Studien von Nutzen, ob sie Studien durchführen und/oder begleiten. Ebenso relevant ist dieses Praktikerbuch für Mitarbeiter bei Regulierungsstellen und im Bereich der Bioethik.