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Data Monitoring Committees (DMCs) Past, Present, and Future /

This book provides an overview of Data Monitoring Committees - 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...

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Enregistré dans:
Détails bibliographiques
Collectivité auteur: SpringerLink (Online service)
Autres auteurs: Rawat, Nand Kishore (Éditeur intellectuel), Kerr, David (Éditeur intellectuel)
Format: Électronique eBook
Langue:anglais
Publié: Cham : Springer International Publishing : Imprint: Springer, 2023.
Édition:1st ed. 2023.
Sujets:
Pharmacology.
Medical sciences.
Drug development.
Medicine > Research.
Biology > Research.
Pharmaceutical chemistry.
Biometry.
Toxicology.
Preclinical Research.
Biomedical Research.
Pharmaceutics.
Biostatistics.
Medical Toxicology.
Accès en ligne:https://doi.org/10.1007/978-3-031-28760-2
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Table des matières:
  • Introduction-.What is a DMC?-. Is a DMC required?-. Who is On the DMC?-. What are the Legal and Ethical Aspects of DMC?-. How does the DMC work with SDAC and Sponsor and External Groups ?
  • What Does a DMC Meeting Look Like
  • What data is used for DMC outputs and who programs?
  • What is Included in DMC Outputs?
  • What does the DMC final DMC outputs look like and how is it delivered?
  • What Types of Safety Outputs Does the DMC Receive?
  • What types of efficacy outputs does the DMC receive?
  • What types of other outputs does the DMC receive?
  • What About In-Between DMC Meetings
  • What types of formal interim analyses does the DMC review?
  • What does the paperwork from meetings look like?
  • How does the DMC assess risk-benefit for their decision making?
  • What are some examples?
  • Conclusions.

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