Abstract
In this chapter, a brief review is provided of the important fundamentals of clinical trial design and analysis that will be required for our subsequent discussions of the multiple analysis issue. The random selection of subjects from the population and the random allocation of therapy is covered. A discussion of the need to blind both patients and investigators to a patient’s therapy assignment and the need for a Data and Safety Monitoring Committee is followed by a brief review of interim monitoring procedures that have become so popular in clinical trials. Finally, the effect of sampling errors in clinical trials is developed. Type I and type II errors are defined and the purpose of the sample size computation is reviewed.
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(2003). Fundamentals of Clinical Trial Design. In: Multiple Analyses in Clinical Trials. Statistics for Biology and Health. Springer, New York, NY. https://doi.org/10.1007/0-387-21813-0_2
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DOI: https://doi.org/10.1007/0-387-21813-0_2
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