• 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 » EMA Plans New Guidance in Response to Increased Use of Platform Trials

EMA Plans New Guidance in Response to Increased Use of Platform Trials

December 5, 2022

The European Medicines Agency (EMA) is planning to draft new guidance on the planning, operational and reporting challenges inherent to platform trials.

The EMA believes that a “consolidated position” is necessary as industry uses the platform design more and more. Specifically, the agency has begun discussing a guidance on multiplicity and adaptive design that will serve to complement its existing platform trial guidances, not replace or revise them.

Through this guidance, the EMA says it will:

  • Clarify terminology and introduce key concepts;
  • Describe key methodological topics unique to platform trials and important design features to help guide trial planning and protocol development; and
  • Outline the Committee for Medicinal Products for Human Use’s position on the increased complexity and uncertainty in decision-making related to platform trials.

The agency said it intends to release a draft guidance in March 2024 and publish the final guidance in December 2024.

Read the EMA’s concept paper here: https://bit.ly/3i5EAmP.

 

To view more CenterWatch Weekly stories, click here.

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

  • SurveywBlueBackground-360x240.png

    Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

  • TrendsInsights2023-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Two

  • TimeMoneyEffort-360x240.png

    Time is Money and So Is Effort, Budgeting Experts Say

  • TrendsInsights2023A-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Three

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