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Data monitoring in clinical trials : a practical perspective /

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autores principales: Ellenberg, Susan Smith (Autor), Fleming, Thomas R. (Autor), DeMets, David L., 1944- (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken, NJ : John Wiley & Sons, Inc., 2019.
Edición:Second edition.
Colección:Statistics in practice.
Temas:
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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.