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Issues in Data Analysis

  • Chapter
Fundamentals of Clinical Trials

Abstract

The analysis of data obtained from a clinical trial represents the outcome of the planning and implementation already described. Primary and secondary questions addressed by the clinical trial can be tested and new hypotheses generated. Data analysis is sometimes viewed as simple and straightforward, requiring little time, effort, or expense. However, careful analysis usually requires a major investment in all three. It must be done with as much care and concern as any of the design or data-gathering aspects. Furthermore, inappropriate statistical analyses can introduce bias, result in misleading conclusions and impair the credibility of the trial.

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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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Friedman, L.M., Furberg, C.D., DeMets, D.L., Reboussin, D.M., Granger, C.B. (2015). Issues in Data Analysis. In: Fundamentals of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-18539-2_18

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