Skip to main content

Ethical and Scientific Issues in Studying the Safety of Approved Drugs (2012) / Chapter Skim
Currently Skimming:

Abstract
Pages 1-2

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 1...
... . No general algorithm can dictate when FDA should require a postmarketing study or what type of studies to require if it makes that decision, but the com mittee identifies circumstances that should cause heightened concern about a drug and the scientific and ethical advantages of various study designs to resolve specific public health questions as they emerge.
Read the entire page →
From page 2...
... Finally, an increased monitoring role requires that FDA establish effective interdisciplinary teams with the expertise necessary to design safety research and interpret resulting data; the necessary expertise goes beyond that necessary for drug approval. The expanded expertise includes observational study design, analysis and interpretation, Bayesian and causal inference methods, ethics, pharmacoepidemiology, outcomes research, and the design and analysis of clinical trials for safety outcomes.
Read the entire page →

Key Terms

  • scientific reasons
  • drug approval
  • ethical advantages
  • increased monitoring
  • required include

  • specific public
  • identifies circumstances
  • interdisciplinary teams
  • heightened concern
  • ing rcts

  • postmarketing study
  • special obligations
  • study design
  • establish effective
  • clinical trials

  • sufficient quality
  • observational designs
  • postmarketing rcts
  • required postmarketing
  • observational study

  • goes beyond
  • mittee identifies
  • health questions
  • expertise includes
  • resolve specific

  • accelerated approval
  • amendments act
  • cause heightened
  • effective interdisciplinary
  • monitoring role


    • This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
    More information on Chapter Skim is available.