Principles of Clinical Research

  • Richard N. Puzzitiello
  • Avinesh Agarwalla
  • Brian Forsythe
  • Natalie L. LeongEmail author


A general understanding of clinical research is necessary both to thoughtfully read orthopedic literature and to contribute to literature by conducting research. This chapter addresses the different types of clinical research, as well as the definitions of the various levels of evidence. Then, a brief history of regulatory guidelines pertaining to human research is provided, along with an overview of current regulatory mechanisms. Other general considerations such as funding sources and challenges of conducting research are also addressed. Finally, a primer of basic statistical principles and calculations frequently used in clinical research is included at the end of the chapter.


Clinical research Basic statistics Levels of evidence Study design 


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© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Richard N. Puzzitiello
    • 1
    • 2
  • Avinesh Agarwalla
    • 1
    • 2
  • Brian Forsythe
    • 1
    • 2
  • Natalie L. Leong
    • 1
    • 2
    Email author
  1. 1.Rush University Medical Center, Midwest Orthopedics at RushChicagoUSA
  2. 2.Department of Orthopedic SurgeryRush University Medical CenterChicagoUSA

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