IDEAS home Printed from https://ideas.repec.org/h/spr/sprchp/978-3-031-26328-6_9.html
   My bibliography  Save this book chapter

Estimand in Real-World Evidence Study: From Frameworks to Application

In: Real-World Evidence in Medical Product Development

Author

Listed:
  • Ying Wu

    (Southern Medical University, Department of Biostatistics)

  • Hongwei Wang

    (Medical Affairs & Health Technology Assessment Statistics, AbbVie)

  • Jie Chen

    (Taimei Technology & Overland Pharma)

  • Hana Lee

    (Food and Drug Administration)

Abstract

The ICH E9(R1) addendum on estimands and sensitivity analysis describes statistical principles for defining estimands in clinical trials with a focus on five attributes—target population, treatment, endpoint, intercurrent events, and population-level summary. Although the addendum states that the principles are also applicable to single-arm trials and observational studies, constructing estimands for real-world evidence (RWE) studies might require additional considerations. This chapter reviews and discusses existing estimand-related frameworks, including the ICH E9(R1), that could potentially serve as guiding principles for defining real-world estimands. This chapter also provides examples of constructing an appropriate estimand in RWE studies, with detailed description on each of the five estimand attributes outlined in ICH E9(R1).

Suggested Citation

  • Ying Wu & Hongwei Wang & Jie Chen & Hana Lee, 2023. "Estimand in Real-World Evidence Study: From Frameworks to Application," Springer Books, in: Weili He & Yixin Fang & Hongwei Wang (ed.), Real-World Evidence in Medical Product Development, pages 145-165, Springer.
    • Handle: RePEc:spr:sprchp:978-3-031-26328-6_9
    DOI: 10.1007/978-3-031-26328-6_9
    as

    Download full text from publisher

    To our knowledge, this item is not available for download. To find whether it is available, there are three options:
    1. Check below whether another version of this item is available online.
    2. Check on the provider's web page whether it is in fact available.
    3. Perform a
    for a similarly titled item that would be available.

    More about this item

    Keywords

    ;
    ;
    ;
    ;
    ;
    ;
    ;
    ;

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:spr:sprchp:978-3-031-26328-6_9. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    We have no bibliographic references for this item. You can help adding them by using this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.