Study Population

Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin and Christopher B. Granger
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Curt D. Furberg: Wake Forest School of Medicine, Division of Public Health Sciences
David L. DeMets: University of Wisconsin, Department Biostatistics and Medical Informatics
David M. Reboussin: Wake Forest School of Medicine, Department of Biostatistics
Christopher B. Granger: Duke University, Department of Medicine

Chapter Chapter 4 in Fundamentals of Clinical Trials, 2015, pp 73-88 from Springer

Abstract: Abstract Defining the study population in the protocol is an integral part of posing the primary question. Additionally, in claiming an intervention is or is not effective it is essential to describe the type of participants on which the intervention was tested. Thus, the description requires two elements: specification of criteria for eligibility and description of who was actually enrolled. This chapter focuses on how to define the study population. In addition, it considers two questions. First, what impact does selection of eligibility criteria have on participant recruitment, or, more generally, study feasibility? Second, to what extent will the results of the trial be generalizable to a broader population? This issue is also discussed in Chap. 10 .

Date: 2015
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DOI: 10.1007/978-3-319-18539-2_4

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