Data and Safety Monitoring Committees in Clinical Trials - Couverture rigide

Herson, Jay

Couverture rigide

ISBN 10 : 1498784100 ISBN 13 : 9781498784108

Editeur : Chapman and Hall/CRC, 2017

Synopsis

Praise for the first edition:

"Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC."

-S. T. Ounpraseuth, The American Statistician

In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff.

The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition.

New to the Second Edition:

• Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives.
• Newly added interim analysis for efficacy and futility section.
• DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc.
• DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan)
• Use of patient reported outcomes of safety
• Use of meta analysis and data outside the trial
• New ideas for training and compensation of DMC members

Jay Herson

is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.

A propos du livre

À propos de l'auteur

Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.

À propos de la quatrième de couverture

Focusing on the practical clinical and statistical issues that arise in pharmaceutical industry trials, this book summarizes the author's experience in serving on many data monitoring committees (DMCs) and in heading up a contract research organization that provided statistical support to nearly seventy-five DMCs. It explains the difference in DMC operations between the pharmaceutical industry and National Institutes of Health (NIH)-sponsored trials.

Détails de l'édition

• Éditeur: Chapman and Hall/CRC
• Date d'édition: 2017
• Langue: anglais
• ISBN 10: 1498784100
• ISBN 13: 9781498784108
• Reliure: Relié
• Numéro d'édition: 2
• Nombre de pages: 241
• Coordonnées du fabricant: non disponible
• Personne responsable: GPSR Kontakt; gpsr@libri.de; ; Europaallee 1; Bad Hersfeld; 36244; Allemagne