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What Is the Question?

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Fundamentals of Clinical Trials

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Abstract

The planning of a clinical trial depends on the question that the investigator is addressing. The general objective is usually obvious, but the specific question to be answered by the trial is often not stated well. Stating the question clearly and in advance encourages proper design. It also enhances the credibility of the findings. One would like answers to a number of questions, but the study should be designed with only one major question in mind. This chapter discusses the selection of this primary question and appropriate ways of answering it. In addition, types of secondary and subsidiary questions are reviewed.

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Author information

Authors and Affiliations

  1. Bethesda, MD, USA

    Lawrence M. Friedman

  2. School of Medicine, Wake Forest University, Winston-Salem, NC, USA

    Curt D. Furberg

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

    David L. DeMets

Authors
  1. Lawrence M. Friedman
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  2. Curt D. Furberg
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  3. David L. DeMets
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Corresponding author

Correspondence to Lawrence M. Friedman .

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© 2010 Springer New York

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Friedman, L.M., Furberg, C.D., DeMets, D.L. (2010). What Is the Question?. In: Fundamentals of Clinical Trials. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-1586-3_3

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