Data monitoring in clinical trials : a practical perspective /

Bibliographic Details
Call Number:Libro Electrónico
Main Authors: Ellenberg, Susan Smith (Author), Fleming, Thomas R. (Author), DeMets, David L., 1944- (Author)
Format: Electronic eBook
Language:Inglés
Published: Hoboken, NJ : John Wiley & Sons, Inc., 2019.
Edition:Second edition.
Series:Statistics in practice.
Subjects:
Clinical trials.
Statistics > Methodology.
Clinical Trials Data Monitoring Committees > organization & administration
Clinical Trials as Topic
Data Collection
Clinical Trials Data Monitoring Committees > ethics
Data Collection > methods
Études cliniques.
Statistique > Méthodologie.
Clinical trials
Online Access:Texto completo
Table of Contents:
  • Responsibilities of the data monitoring committee and motivating illustrations
  • Composition of a data monitoring committee
  • Independence of the data monitoring committee : avoiding conflicts of interest
  • Confidentiality issues relating to the data monitoring committee
  • Data monitoring committee meetings
  • Data monitoring committee interactions with other trial components or related groups
  • Statistical, philosophical and ethical issues in data monitoring
  • Determining when a data monitoring committee is needed
  • Regulatory considerations for the operation of data monitoring committees
  • Legal considerations for DMCs.

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