IDEAS home Printed from https://ideas.repec.org/a/abf/journl/v58y2024i1p49952-49966.html
   My bibliography  Save this article

Real-world Evidence Requirements with Respect to External Control Arms of Single-arm Clinical Trials by Major Regulatory and HTA Agencies – Comparative Review of Guidelines and Identification of Trends Based on Seven Recent Case Studies

Author

Listed:
  • Volker Schuster
  • Anna Tena Marco

    (SAI MedPartners, Neuhofstrasse 12, 6341 Baar, Switzerland)

Abstract

Shifting R&D focus towards the (ultra-)rare diseases and precision medicine leads to a rising need to assess single-arm clinical trials for regulatory and HTA purposes. While numerous time-tested methods exist to utilize real-world evidence as external control groups while limiting the confounding risk, there is still limited international consensus on how to generate, curate and use real-world-data in order to serve as acceptable external control.

Suggested Citation

  • Volker Schuster & Anna Tena Marco, 2024. "Real-world Evidence Requirements with Respect to External Control Arms of Single-arm Clinical Trials by Major Regulatory and HTA Agencies – Comparative Review of Guidelines and Identification of Tre," Biomedical Journal of Scientific & Technical Research, Biomedical Research Network+, LLC, vol. 58(1), pages 49952-49966, August.
    • Handle: RePEc:abf:journl:v:58:y:2024:i:1:p:49952-49966
    DOI: 10.26717/BJSTR.2024.58.009096
    as

    Download full text from publisher

    File URL: https://biomedres.us/pdfs/BJSTR.MS.ID.009096.pdf
    Download Restriction: no
    File URL: https://biomedres.us/fulltexts/BJSTR.MS.ID.009096.php
    Download Restriction: no
    File URL: https://libkey.io/10.26717/BJSTR.2024.58.009096?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
    ---><---

    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:abf:journl:v:58:y:2024:i:1:p:49952-49966. 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: Angela Roy (email available below). General contact details of provider: .

    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.