• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Endpoint Analysis in Eosinophilic Esophagitis Trials Gets FDA Overhaul

Endpoint Analysis in Eosinophilic Esophagitis Trials Gets FDA Overhaul

September 21, 2020

Trials of drugs or biologics to treat eosinophilic esophagitis should develop their own patient-reported outcome (PRO) tools in the absence of well-defined and reliable instruments for the disease, according to a final guidance the FDA released last week.

New instruments should be tested in phase 2 trials to help determine endpoints and scoring algorithms for phase 3 trials, says the guidance that was first released as a draft in February 2019.

Trials should include a treatment period of at least 24 weeks to assess the drug’s effect on signs and symptoms and the related underlying inflammation, followed by an additional 28 weeks of treatment to establish the treatment’s safety and durability of response. Sponsors should gather long-term data before submitting an application to the FDA.

The agency encourages the inclusion of patients age 12 to 17 in trials as long as data from adult patients shows the treatment is safe, and trial designs for patients younger than age 12 may be considered based on safety data from adult and adolescent populations.

Read the final guidance here: https://bit.ly/3kpx5CX.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Revamp-360x240.png

    Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

  • AskTheExpertsGreen-360x240.png

    Ask the Experts: Managing Investigational Products

  • SurveywBlueBackground-360x240.png

    Survey Outlines Site Challenges, Successes on Diversity

  • PatientCentricity-360x240.png

    Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing