Informing ICH E6 Renovation

Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice

JUNE 04, 2020 TO JUNE 05, 2020

CTTI Project: Informing ICH E6 Renovation

Meeting Overview:

The U.S. Food and Drug Administration, in collaboration with the Clinical Trials Transformation Initiative, is organizing a free two-day Pan-American-focused public web conference on Thursday, June 4, and Friday, June 5, from 10:00 a.m. - 1:00 p.m. EDT, to learn more about stakeholder experiences with the International Council for Harmonisation (ICH) Good Clinical Practice guideline (ICH E6).

This stakeholder engagement web conference will inform the discussions of the ICH Expert Working Group (EWG), which is tasked with updating the guideline and making it more responsive to advances in clinical trial design and conduct. Members of the EWG will provide an overview of the ongoing work to update the guideline and will then hear from multiple stakeholders on their experiences with ICH E6(R2).

The registration process gives registrants an opportunity to submit questions. We will address themes from questions submitted before Tuesday, May 26, during a session on Friday, June 5. Please note the following regarding submissions:

  • Submissions must be in English.
  • Anyone can submit questions or comments.

Time slots for stakeholders to provide oral comments during the second day of the web conference are now filled. Please consider submitting questions when registering or sending written comments to cttievents@dm.duke.edu (External Link Disclaimer).

For additional information on the ICH E6 revision efforts, please refer to the following materials:

Meeting details are available on FDA’s website.

Meeting Location:

Virtual Meeting

Meeting Agenda

Meeting Summary

Meeting Materials:

Day 1

Session I: Introduction/ICH Process & Updating ICH E6 GCP Guidelines

Session II: CTTI ICH E6 Survey and Stakeholder Input

Session III: Perspectives from EWG Members

Session IV: Perspectives from Clinical Investigators

Session V: Perspectives from Patient Organizations

Day 2

Session I: Stakeholders Perspectives

Session II: Moderated Discussion of Themes from Stakeholders

Session III: Stakeholder Comments

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

ICH E6 Guideline for Good Clinical Practice – Update on Progress

MAY 18, 2021 TO MAY 19, 2021

CTTI Project: Informing the Update of ICH E6

On behalf of the International Council for Harmonisation (ICH), the ICH E6 Good Clinical Practice (GCP) Expert Working Group (EWG) held a free public web conference to provide an update on the progress to revise this important and impactful guideline. This web conference was convened by the Clinical Trials Transformation Initiative (CTTI).

The EWG held two similar meetings on Tuesday, May 18, 2021 (8-11 a.m. EDT) and Wednesday, May 19, 2021 (6-9 pm JST) to reach a broad global audience across time zones. As you will note on the agenda, the same topics were presented each day with speakers from different regions to represent the global effort. All information and presentations was provided in English.

Recorded presentations of the public web conferences are available above.

Meeting Location:

Virtual Meeting

Meeting Agenda - May 18

Meeting Agenda - May 19

Meeting Summary

Meeting Materials:

Video: ICH Guideline Development Process

Watch May 18 Web Conference

Watch May 19 Web Conference

 

Presentations:

Session 1 – General Introduction

Session 2 – E6(R3) GCP Expert Working Group (EWG) Vision & Engagement

Session 3 – Principles & Stakeholder Reflections

Full Web Conference Slide Deck

 

Additional Meeting Details:

ICH E6 GCP is the international ethical, scientific, and quality standard for the conduct of clinical trials for the development of new drugs and biologics involving human participants that are intended to support regulatory applications. Due to the wide impact of this important guideline, the ICH Management Committee is taking this unique step to provide a status update on the revisions to the guideline.

In this web conference, members of the ICH E6 EWG discussed the work-in-progress to develop principles and annexes for ICH E6 GCP (third version or E6(R3)) that are intended to be responsive across clinical trial types and settings and to remain relevant as technology and methodologies advance. The draft, work-in-progress principles that were made public by the ICH on April 19, 2021, are designed to be flexible and applicable to a broad range of clinical trials. View the principles on the ICH website. The EWG is not taking public comments on the principles at this stage. However, once the ICH E6 guideline achieves step 3 of the ICH guideline development process, the EWG will invite and consider public input.

The EWG also discussed its plans and approaches to update the guideline in general and its engagement efforts with a variety of stakeholders that greatly enriched the discussions of the EWG. As part of these continued efforts to engage with stakeholders, the web conference included presentations from stakeholders on their vision and aspiration for clinical trial design and conduct that are responsive to the needs of the community.

View the full conference agenda here. For additional information on the ICH E6 revision efforts, please see the Reflection Paper on Renovation of Good Clinical Practice and the Concept Paper. For further information on the engagement approach, please see the published outline of the ICH E6 engagement proposal. Other materials, including the current guideline, "ICH E6(R2): Guideline for Good Clinical Practice," the business plan, work plan, an expert list, and reports of prior public engagements are available on the ICH website: https://www.ich.org/page/efficacy-guidelines.

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Report Now Available: ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress

Posted on by Hannah Faulkner

The report of the public web conference on “ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress,” organized by International Council for Harmonisation (ICH) and convened by the Clinical Trials Transformation Initiative (CTTI), is now available.  The web conference, which consisted of identical meetings at different times on May 18 & 19 to accommodate a global audience, reached more than 5100 attendees.

The ICH E6 Expert Working Group (EWG) members, who are updating the guideline, presented a video wherein they shared the ICH guideline development process and the approach to updating ICH E6  The video was followed by presentations on the vision and goals for updating the ICH E6 guideline and on lessons learned from public input and stakeholder feedback on the ICH E6 revision process.  In the final session, EWG members discussed the draft principles, which were published in April.  Key stakeholders closed the web conference by sharing their visions and aspirations for clinical trials.

Check out the recording and the slide decks for each day of the web conference to learn more from the presenters.

For additional information on updating the ICH E6, please refer to the following materials:

 

 

Recording of Public Web Conference Now Available: Listen to ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress

Posted on by Hannah Faulkner

Recordings for the International Council for Harmonisation’s public web conference, held May 18 & 19, “ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress,” are now available.

The web conference, which consisted of identical meetings at different times over two days to accommodate a global audience, opened with welcoming remarks followed by a video session wherein ICH E6 Expert Working Group (EWG) members shared the ICH guideline development process and the approach to updating ICH E6(R3). The second session of the web conference focused on the vision and goals for the work to update the E6 guideline and lessons learned from public input and stakeholder feedback. In the final session of the web conference, members of the EWG presented the published draft, work-in-progress principles. Then, experts and advocates provided their vision and aspirations on the clinical trial enterprise in general.

View the full slide deck for day of the web conference to learn more from each presenter.

For additional information on updating the ICH E6, please refer to the following materials:

Report Now Available: Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice

Posted on by Hannah Faulkner

The summary report of the web conference on “Stakeholder Engagement on ICH E6 Guidance for Good Clinical Practice,” organized by the U.S. Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI), is now available. The two-day Pan-American web conference was held June 4-5 with more than 1300 attendees worldwide.

The report provides an overview of the presentations from a diverse group of participants, including academic researchers, human subject protection and ethics experts, as well as patients. Members of the ICH Expert Working Group (EWG), which is tasked with updating the ICH E6 guideline, provided an overview of their approach to ensuring that the guideline is responsive to the needs of the community and that it facilitates advances in clinical trial design and conduct. The report also outlines key themes from the web conference’s line-up of stakeholders who shared their experiences with ICH E6(R2).  Further, the report also incorporates comments and input from web-conference attendees that were received via email or verbally during the web conference.

Check out the recording and the slide decks for each day of the web conference to learn more from the presenters.

For additional information on the ICH E6 revision efforts, please refer to the following materials:

Web Conference Recordings Available: Listen to Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice

Posted on by Hannah Faulkner

A recording for FDA and CTTI’s two-day Pan-American web conference held June 4-5, “Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice,” is now available.

Khair ElZarrad, FDA, and Pamela Tenaerts, CTTI, opened the web conference by welcoming attendees. Then, FDA and CTTI shared background on ICH E6 and the plan to engage with stakeholders to inform the discussions of the ICH Expert Working Group (EWG), which is tasked with updating the guideline and making it more responsive to advances in clinical trial design and conduct. Multiple stakeholders then shared their experiences with ICH E6(R2). Overall, the web conference was a testament to the importance of having engagement at the heart of the development of E6.

View the slide decks for each day of the web conference to learn more from each presenter.

For additional information on the ICH E6 revision efforts, please refer to the following materials: