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Postmarketing Cardiovascular Safety Considerations

  • J. Rick Turner
  • Dilip R. Karnad
  • Snehal Kothari
Chapter

Abstract

The fundamental importance of safety assessments has been emphasized many times in previous chapters. We have discussed “engineering safety” into new molecular entities, safety evaluations in nonclinical studies, and safety evaluations in preapproval clinical trials. While data collected in preapproval investigations and clinical trials are clearly very important, it is appropriate here to acknowledge that they have limitations. With regard to preapproval clinical research, Olsson and Meyboom (2006, p. 229) commented as follows:Given our focus on preapproval randomized clinical trials to date, these statements may initially sound somewhat surprising. However, they are true. The strength of preapproval randomized clinical trials is that they are comparative, not necessarily representative (see Senn, 2007): they are essential to the process of new drug development, but evaluation of a drug must not stop once marketing approval has been granted. As the Institute of Medicine of the National Academies (2007) observed, “The approval decision does not represent a singular moment of clarity about the risks and benefits associated with a drug – preapproval clinical trials do not obviate continuing formal evaluations after approval.” The necessity for both pre- and post-approval clinical investigations is captured in the term lifecycle clinical development.

Keywords

Electronic Health Record Marketing Approval Risk Balance National Cardiovascular Data Registry Individual Clinical Expertise 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer International Publishing Switzerland 2017

Authors and Affiliations

  • J. Rick Turner
    • 1
  • Dilip R. Karnad
    • 2
  • Snehal Kothari
    • 3
  1. 1.Cardiac Safety Services QuintilesDurhamUSA
  2. 2.Research TeamCardiac Safety Services QuintilesMumbaiIndia
  3. 3.Cardiac Safety Services Global HeadCardiac Safety Center of Excellence QuintilesMumbaiIndia

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