What Is the Question?

Lawrence M. Friedman (), Curt D. Furberg () and David L. DeMets ()
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Curt D. Furberg: Wake Forest University, School of Medicine
David L. DeMets: University of Wisconsin, Department of Biostatistics & Medical Informatics

Chapter Chapter 3 in Fundamentals of Clinical Trials, 2010, pp 37-53 from Springer

Abstract: Abstract The planning of a clinical trial depends on the question that the investigator is addressing. The general objective is usually obvious, but the specific question to be answered by the trial is often not stated well. Stating the question clearly and in advance encourages proper design. It also enhances the credibility of the findings. One would like answers to a number of questions, but the study should be designed with only one major question in mind. This chapter discusses the selection of this primary question and appropriate ways of answering it. In addition, types of secondary and subsidiary questions are reviewed.

Keywords: Response Variable; Total Mortality; Nonfatal Myocardial Infarction; Primary Question; Noninferiority Trial (search for similar items in EconPapers)
Date: 2010
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DOI: 10.1007/978-1-4419-1586-3_3

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