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Study Population

  • Chapter
Fundamentals of Clinical Trials

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.

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Author information

Authors and Affiliations

  1. North Bethesda, MD, USA

    Lawrence M. Friedman

  2. Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA

    Curt D. Furberg

  3. Department Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA

    David L. DeMets

  4. Department of Biostatistics, Wake Forest School of Medicine, Winston-Salem, NC, USA

    David M. Reboussin

  5. Department of Medicine, Duke University, Durham, NC, USA

    Christopher B. Granger

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  1. Lawrence M. Friedman
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  2. Curt D. Furberg
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  4. David M. Reboussin
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  5. Christopher B. Granger
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© 2015 Springer International Publishing Switzerland

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Friedman, L.M., Furberg, C.D., DeMets, D.L., Reboussin, D.M., Granger, C.B. (2015). Study Population. In: Fundamentals of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-18539-2_4

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