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Bücher Englische Bücher Wissen & Bildung Naturwissenschaft, Medizin, Informatik, Technik Medizin Pharmazie Data Monitoring Committees (DMCs)
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Data Monitoring Committees (DMCs)
(Gebundene Ausgabe, Englisch)
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Beschreibung
This book provides an overview of Data Monitoring Committees(DMC) - what was done in the past, what is currently being done, and thoughts on improvements for the future. Previous works focused primarily on large cardiovascular studies (where DMCs originated more than 30 years ago) but updated references are needed that discuss smaller, more flexible studies in areas such as oncology. The authors… have attended ~800 DMC meetings from ~200 distinct studies across all areas of clinical studies (oncology, rheumatology, rare diseases, cardiology, immunology, etc.) This wide range of expertise will be used, as well as the expertise that comes from working with virtually every large biotechnology and pharmaceutical company and CRO for DMC work. The reader of the book will know when DMCs are needed or helpful, how to form the DMC, how to work with external CROs and with sponsor teams and the DMC to create needed DMC outputs, how the DMC meetings are conducted, and - especially for DMC members - what are considerations within the Closed Session to review safety/efficacy outputs to assess risk/benefit to make appropriate recommendations that protect the patient safety and trial integrity. This is a practical hands-on book on how to decide if a DMC is necessary, how to form the DMC, how to expertly create the necessary materials for the DMC and have smooth running DMC meetings. There is no specialized training in school about how DMCs work - frequently people may have been in industry for many years without ever needing to work with a DMC. This book is the helpful reference for those new to these DMCs. The DMC work is critical to be correctly implemented as the impact of DMC activity on safeguarding the trial is so important. This book provides the following: Provides thorough instructions on the steps needed to form and implement a Data Monitoring Committee for clinical trial evaluation; Includes practical and hands-on information on DMC implementation; Discusses a wide range of clinical trial – by phase and therapeutic area. Dieses Produkt haben wir gerade leider nicht auf Lager.
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Technische Daten
Erscheinungsdatum
09.06.2023
Sprache
Englisch
EAN
9783031287596
Herausgeber
Springer International Publishing
Sonderedition
Nein
Seitenanzahl
111
Einbandart
Gebundene Ausgabe
Buch Untertitel
Past, Present, and Future
Schlagwörter
Clinical Trials drug approval, Clinical trials vaccine approval, FDA drug approval, unbiased review of clinical trials, statistical analysis of clinical trials data
Thema-Inhalt
MKG - Pharmakologie
MBGR - Medizinische Forschung
PNB - Medizinische Chemie, Pharmazeutische Chemie
PBT - Wahrscheinlichkeitsrechnung und Statistik
MKGT - Medizinische Toxikologie
Höhe
235 mm
Breite
15.5 cm
Hersteller: Springer, Europaplatz 3, Heidelberg, Deutschland, 69115, ProductSafety@springernature.com, Springer Nature Customer Service Center GmbH
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