IDEAS home Printed from https://ideas.repec.org/a/taf/japsta/v50y2023i9p2055-2078.html
   My bibliography  Save this article

Evaluation of phase I clinical trial designs for combinational agents along with guidance based on simulation studies

Author

Listed:
  • Shu Wang
  • Elias Sayour
  • Ji-Hyun Lee

Abstract

Combinational therapy that combines two or more therapeutic agents is very common in cancer treatment. Currently, many clinical trials aim to assess feasibility, safety and activity of combinational therapeutics to achieve synergistic response. Dose-finding for combinational agents is considerably more complex than single agent, because only partial order of dose combinations' toxicity is known. Prototypical phase I designs may not adequately capture this complexity thus limiting identification of the maximum tolerated dose (MTD) of combinational agents. In response, novel phase I clinical trial designs for combinational agents have been extensively proposed. However, with so many available designs, studies that compare their performances and explore the impact of design parameters, along with providing recommendations are limited. We are evaluating available phase I designs that identify a single MTD for combinational agents using simulation studies under various conditions. We are also exploring the influences of different design parameters and summarizing the risks/benefits of each design to provide general guidance in design selection.

Suggested Citation

  • Shu Wang & Elias Sayour & Ji-Hyun Lee, 2023. "Evaluation of phase I clinical trial designs for combinational agents along with guidance based on simulation studies," Journal of Applied Statistics, Taylor & Francis Journals, vol. 50(9), pages 2055-2078, July.
    • Handle: RePEc:taf:japsta:v:50:y:2023:i:9:p:2055-2078
    DOI: 10.1080/02664763.2022.2105827
    as

    Download full text from publisher

    File URL: http://hdl.handle.net/10.1080/02664763.2022.2105827
    Download Restriction: Access to full text is restricted to subscribers.
    File URL: https://libkey.io/10.1080/02664763.2022.2105827?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    More about this item

    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:taf:japsta:v:50:y:2023:i:9:p:2055-2078. 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: Chris Longhurst (email available below). General contact details of provider: http://www.tandfonline.com/CJAS20 .

    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.