Clinical Trials in Sudden Cardiac Death Prevention: Principles and Endpoints

  • Andrzej S. Kosinski


A properly designed and conducted randomized clinical trial is the most objective approach for definitive comparison of medical therapies. However, a clinical trial is a complex collaborative undertaking and requires substantial multidisciplinary planning efforts. This chapter presents the main components of a randomized trial and discusses the essential statistical concepts relevant in a trial design. The primary result and summary of statistical power, analysis, and the follow-up approach of the four recently completed pivotal clinical trials pertinent to the prevention of sudden cardiac death are summarized.


Randomized controlled trial Intention-to-treat principle Informed consent Data Safety Monitoring Board Type I error Primary endpoint test statistic Treatment effect Statistical power Sample size Subgroup and interim analyses 


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Copyright information

© Springer-Verlag London 2013

Authors and Affiliations

  1. 1.Department of Biostatistics and BioinformaticsDuke University School of Medicine, Duke Clinical Research InstituteDurhamUSA

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