• 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
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » ICH Releases Draft Revision of Guideline on General Trial Design and Conduct

ICH Releases Draft Revision of Guideline on General Trial Design and Conduct

May 13, 2019
Leslie Ramsey

Sponsors, sites and CROs have the chance to weigh in on the first draft revision of ICH E8 since it was adopted in 1997. Changes to trial design and conduct in the last two decades have made much of the guideline out of date.

ICH has been working to modernize its suite of clinical research guidelines since 2017, when it issued a major revision of ICH E6 and now has turned to the next guideline on its modernization schedule, ICH E8 — General Considerations for Clinical Trials.

The proposed 33-page revision adds a new section on designing quality into clinical studies that focuses on the need to identify a basic set of “critical-to-quality” factors that the guideline defines as “attributes of a study whose integrity is fundamental to the protection of study subjects, the reliability and interpretability of the study results and the decisions made based on the study results.” Those factors should be adaptable to a variety of trial designs, the guideline says.

The new document also emphasizes the importance of patient centricity in trial development. “Involving patients at the early stage of study design is likely to increase trust in the study, facilitate recruitment and promote adherence, which should continue throughout the duration of the study,” the guideline says. Also new to the guideline — almost triple the length of the original E8 — are sections on design elements for clinical studies and trial conduct and reporting.

ICH is seeking comments on the draft by October and plans to release the final ICH E8(R1) by June 2020.

Read the draft guideline here: https://bit.ly/2Jyzzjl.

Send comments: step2comments@ich.org.

Upcoming Events

  • 17May

    Three Data Trends to Consider Now When Developing Your Decentralized Clinical Trial Strategy

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

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

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

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 My Personal Information

Footer Logo

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

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing