Reviewing the Literature, Developing a Hypothesis, Study Design

  • C. Max Schmidt


Rigorous research investigation requires a thorough review of the literature on the topic of interest. This promotes development of an original, relevant, and feasible hypothesis. Design of an optimal study to test the hypothesis then requires adequate power, freedom from bias, and conduct within a reasonable timeframe with resources available to the investigator.


Literature review Hypothesis Study design Power Bias Validity Alpha error Randomized trial 



Financial Support: Indiana Genomics Initiative (INGEN) of Indiana University. INGEN is supported in part by Lilly Endowment Inc. (CMS).

I would like to thank Dr. Carl Schmidt, MD, MSCI, Assistant Professor Surgery, the Ohio State University, for his expertise and critical review of this chapter.

Selected Readings

  1.  .
    Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials. 4th ed. New York: Springer; 1998.Google Scholar
  2.  .
    Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB. Designing Clinical Research. 3rd ed. Philadelphia: Lippincott Williams & Wilkins; 2007.Google Scholar
  3.  .
    Penson DF, Wei J. Clinical Research Methods for Surgeons. Totowa: Humana Press; 2006.Google Scholar
  4.  .
    Piantadosi S. Clinical Trials: A Methodological Perspective. 2nd ed. New York: Wiley; 2005.Google Scholar

Copyright information

© Springer-Verlag London Limited 2011

Authors and Affiliations

  • C. Max Schmidt
    • 1
  1. 1.Department of Surgery, Department of Biochemistry and Molecular BiologyIndiana University School of MedicineIndianapolisUSA

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