Abstract
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.
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Kosinski, A.S. (2013). Clinical Trials in Sudden Cardiac Death Prevention: Principles and Endpoints. In: Gussak, I., Antzelevitch, C. (eds) Electrical Diseases of the Heart. Springer, London. https://doi.org/10.1007/978-1-4471-4978-1_31
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DOI: https://doi.org/10.1007/978-1-4471-4978-1_31
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