Skip to main content
Beth Israel Deaconess Medical Center
Home
  • Join
  • Sign In
  • Join
  • Sign In
  • Events
  • Blog
  • Library
  • Directories
  • News
  • Forums
  • About Us
  • Members
  • Search
  • Groups
  • Courses

Section Menu

  • Events
  • Forums
  • Directories
  • News
  • Library
  • Groups
  • Courses
  • Blog
  • About Us
  • Search

Breadcrumb

  1. DCI Network
  2. Library
  3. Comparing clinical trial population representativeness to real-world populations: an external validity analysis encompassing 43 895 trials and 5 685 738 individuals across 989 unique drugs and 286 conditions in England

Primary tabs

  • View(active tab)
  • Revisions

Comparing clinical trial population representativeness to real-world populations: an external validity analysis encompassing 43 895 trials and 5 685 738 individuals across 989 unique drugs and 286 conditions in England

Click Here To View This Resource The content of this link is external and not affiliated with this site.
  • Description
Authors
  • Yen Yi Tan, Vaclav Papez, Wai Hoong Chang, Stefanie H Mueller, Spiros Denaxas, Alvina G Lai
Description
Randomized controlled trials (RCTs) inform prescription guidelines, but stringent eligibility criteria exclude individuals with vulnerable characteristics, which we define as comorbidities, concomitant medication use, and vulnerabilities due to age. Poor external validity can result in inadequate treatment decision information. Our first aim was to quantify the extent of exclusion of individuals with vulnerable characteristics from RCTs for all prescription drugs. Our second aim was to quantify the prevalence of individuals with vulnerable characteristics from population electronic health records who are actively prescribed such drugs. In tandem, these two aims will allow us to assess the representativeness between RCT and real-world populations and identify vulnerable populations potentially at risk of inadequate treatment decision information. When a vulnerable population is highly excluded from RCTs but has a high prevalence of individuals actively being prescribed the same medication, there is likely to be a gap in treatment decision information. Our third aim was to investigate the use of real-world evidence in contributing towards quantifying missing treatment risk or benefit through an observational study.
Publication Date

20 September 2022

Posted On

27 September 2022

Licensing Information

All Rights Reserved

  • Comments

Member Organizations

  • Logo for BIDMC

Contact

  • (617) 975-7646
  • yquintan@bidmc.harvard.edu
  • Yuri Quintana, Ph.D., Chief of the Division of Clinical Informatics, 133 Brookline Avenue, HVMA Annex, Suite 2200, Boston, MA 02215

Connect

Newsletter

Globe Logo DCI Network Logo Connecting Leaders
  • Events
  • Forums
  • Directories
  • News
  • Library
  • Groups
  • Courses
  • Blog
  • About Us
  • Search
  • Memberships
  • Featured Areas
  • Privacy Policy
  • Terms of Use
  • Contact Us
Copyright © 2022 Beth Israel Deaconess. All Rights Reserved. Powered by Alicanto 2.0