IDEAS home Printed from https://ideas.repec.org/h/spr/sprchp/978-3-319-52636-2_104.html
   My bibliography  Save this book chapter

Randomized Discontinuation Trials

In: Principles and Practice of Clinical Trials

Author

Listed:
  • Valerii V. Fedorov

    (ICON)

Abstract

Randomized discontinuation trials are usually considered as a special case of population enrichment trials. Most often they consist of a few stages with the early ones targeting the selection of a subpopulation that responds or may respond to an experimental treatment and allowing an early escape of patients doing poorly. The succeeding stages validate the treatment’s superiority to placebo or more generally to a comparator for the selected (enriched with potential responders) subpopulation. The approach increases the trial feasibility and the chances of correct response-to-treatment detection, often at the expense of decreased ability to extrapolate results over the initially targeted population. The first randomized discontinuation trials were used exclusively to test long-term, non-curative therapies for chronic or slow evolving diseases. The development of stochastic longitudinal models combined with Bayesian ideas and the increase of computing power led to their acceptance in various therapeutic areas, most notably in oncology. If the statistically valid partitioning of the source population is proven, then it might be viewed as evidence of the existence of some classifiers and pave the road to precision medicine.

Suggested Citation

  • Valerii V. Fedorov, 2022. "Randomized Discontinuation Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 75, pages 1439-1453, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_104
    DOI: 10.1007/978-3-319-52636-2_104
    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:978-3-319-52636-2_104. 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.