Study Population

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 4 in Fundamentals of Clinical Trials, 2010, pp 55-66 from Springer

Abstract: Abstract Defining the study population is an integral part of posing the primary question. It is not enough to claim that an intervention is or is not effective without describing the type of participant on which the intervention was tested. The description requires specification of criteria for eligibility. This chapter focuses on how to define the study population. In addition, it considers two questions. First, to what extent will the results of the trial be generalizable to a broader population? Second, what impact does selection of eligibility criteria have on participant recruitment, or, more generally, study feasibility? This issue is also discussed in Chap. 10.

Keywords: Diastolic Blood Pressure; Eligibility Criterion; Lipid Research Clinic; Participant Safety; Coronary Artery Surgery Study (search for similar items in EconPapers)
Date: 2010
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DOI: 10.1007/978-1-4419-1586-3_4

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