IDEAS home Printed from https://ideas.repec.org/p/ohe/respap/001998.html
   My bibliography  Save this paper

Understanding the Context, Selecting the Standards: A Framework to Guide the Optimal Development and Use of Real-World Evidence for Coverage and Formulary Decisions

Author

Listed:
  • Pearson, S.
  • Dreitlein, B.
  • Towse, A.
  • Hampson, G.
  • Henshall, C.

Abstract

OHE Research Paper 18/02 - Real World Evidence (RWE) – This paper provides a framework and specific steps to help both manufacturers and payers meet the challenge of developing observational RWE through a transparent process that can be considered credible by all stakeholders. It presents a new conceptual framework to address three elements largely missing from these earlier efforts focused on defining "best practices" or "standards" for RWE. These are - 1) how to understand the role that contextual factors play in determining how high the evidentiary standard, or "bar" will be in each situation; 2) how to tailor key process and methodological approaches the height of that evidentiary bar; and 3) how to ensure that broader process principles that support transparency are integrated successfully throughout the course of any RWE initiative. This paper is a companion piece to a [detailed background paper on the use of RWE]( https://www.ohe.org/publications/real-world-evidence-coverage-decisions-opportunities-and-challenges#overlay-context=user) in coverage decisions developed for the Institute for Clinical and Economic Review (ICER) Policy Summit held in December 2017.

Suggested Citation

  • Pearson, S. & Dreitlein, B. & Towse, A. & Hampson, G. & Henshall, C., 2018. "Understanding the Context, Selecting the Standards: A Framework to Guide the Optimal Development and Use of Real-World Evidence for Coverage and Formulary Decisions," Research Papers 001998, Office of Health Economics.
  • Handle: RePEc:ohe:respap:001998
    as

    Download full text from publisher

    File URL: https://www.ohe.org/system/files/private/publications/ICER%20RWE%20Understanding%20the%20Context%20Selecting%20Standards_0.pdf
    Download Restriction: no

    More about this item

    Keywords

    Judging value for money and improving decision making;

    JEL classification:

    • I1 - Health, Education, and Welfare - - Health

    NEP fields

    This paper has been announced in the following NEP Reports:

    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:ohe:respap:001998. See general information about how to correct material in RePEc.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: (Publications Manager). General contact details of provider: http://edirc.repec.org/data/ohecouk.html .

    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 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.

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

    IDEAS is a RePEc service hosted by the Research Division of the Federal Reserve Bank of St. Louis . RePEc uses bibliographic data supplied by the respective publishers.