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Analysis Populations in Anti-Infective Clinical Trials: Whom to Analyze?

  1. Author:
    Evans, Scott
    Rubin, Daniel B
    Powers,John
    Follmann, Dean

  2. Author Address

    Department of Epidemiology and Biostatistics, Milken Institute School of Public Health of The George Washington University, Innovations in Design, Education, and Analysis (IDEA) Committee ,The Biostatistics Center, 6610 Executive Blvd., Suite 750 Rockville, United States of America, SCID@degruyter.com., Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Clinical Research Directorate/Clinical Monitoring Research Program,Leidos Biomedical Research, Inc., NCI Campus at Frederick, Frederick, MD 21702, USA., George Washington University School of Medicine, Washington DC, USA., National Institute of Allergy and Infectious Diseases of the National Institutes of Health, Rockville, United States of America.,
    1. Year: 2018
    2. Date: Dec
    3. Epub Date: 2018 08 29
  2. Journal: Statistical communications in infectious diseases
    1. 10
    2. 1
    3. Pages: pii: 20170002.
  4. Type of Article: Article
  1. Abstract:

    Investigators can choose to analyze different patient populations in clinical trials. The different analysis populations answer different types of research questions, estimate different quantities, and evaluate the robustness of the trial results. Various analysis populations have different strengths and weaknesses depending on the type of question being addressed and the potential for bias from the selection of various groups of trial participants. We discuss analysis populations in the context of anti-infective clinical trials.

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External Sources

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  2. DOI: 10.1515/scid-2017-0002
  3. PMID: 30923606
  4. PMCID: PMC6433381

Library Notes

  1. Fiscal Year: FY2017-2018
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