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Study Population

In: Fundamentals of Clinical Trials

Author

Listed:
  • Lawrence M. Friedman
  • 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)

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 .

Suggested Citation

  • Lawrence M. Friedman & Curt D. Furberg & David L. DeMets & David M. Reboussin & Christopher B. Granger, 2015. "Study Population," Springer Books, in: Fundamentals of Clinical Trials, edition 0, chapter 0, pages 73-88, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-18539-2_4
    DOI: 10.1007/978-3-319-18539-2_4
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