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Efficacy Assessment

  • J. Rick Turner
Chapter

Abstract

In addition to having an acceptable safety profile, an investigational drug needs to display beneficial therapeutic effects for it to receive marketing approval, that is, it needs to have a favorable benefit–risk profile. Therapeutic benefit, operationalized as efficacy, is evaluated in therapeutic exploratory and therapeutic confirmatory trials, trials in which the subjects have the disease or condition of biological concern.

Keywords

Interim Analysis Adaptive Design Statistical Analysis Plan Equivalence Trial Superiority Trial 
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.

Further Readings

  1. Cook TD, DeMets DL (Eds), 2008, Introduction to Statistical Methods for Clinical Trials. Boca Raton, FL: Chapman & Hall/CRC.Google Scholar
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  12. Faich GA, Stemhagen A, 2005, Cardiac arrhythmia assessments in Phase IV clinical studies. In Morganroth JM, Gussak I (Eds), Cardiac Safety of Noncardiac Drugs: Practical Guidelines for Clinical Research and Drug Development. Totowa, NJ: Humana Press, 229–237.CrossRefGoogle Scholar
  13. Matthews JNS, 2006, Introduction to Randomized Controlled Clinical Trials, 2nd Edition. Boca Raton: Chapman & Hall/CRC.CrossRefGoogle Scholar
  14. Spiegelhalter DJ, Abrams KR, Myles JP, 2004, Bayesian Approaches to Clinical Trials and Health-care Evaluation. Hoboken, NJ: Wiley.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  1. 1.Cardiac Safety Services QuintilesDurhamUSA

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