Public Web Conference Report: Stakeholder Engagement on ICH E6 Guideline for GCP
Informing ICH E6 Renovation
Web Conference Recordings Available: Listen to Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice
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:
- ICH E6 main page (www.ich.org)
- ICH E6(R3) Concept Paper
- Summary of the ICH E6 engagement proposal
- CTTI’s ICH E6 Renovation Work
FDA to Organize Two-Day Web Conference with CTTI to Gather Feedback from Stakeholders to Update ICH E6
The International Council for Harmonisation (ICH) is revising ICH E6 Good Clinical Practice (GCP) and requests stakeholder feedback to inform the process. The U.S. Food and Drug Administration, in collaboration with CTTI, will help connect the issues by organizing a free two-day public web conference for discussion of ICH E6 on Thursday, June 4, and Friday, June 5, from 10:00 a.m. – 1:00 p.m. EDT.
This public web conference, “Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice,” will help the ICH Expert Working Group (EWG), which is tasked with updating this guideline, learn from stakeholder experiences with the current GCP guideline (ICH E6(R2)). The conference will also allow the EWG to reflect on the guideline’s applicability to the changing clinical trials landscape. Topics for discussion will include:
- Experiences with applying the current guideline to clinical trials
- Applying GCP to innovative trial designs
- Digital technology tools and GCP
- Other topics relating to GCP
This stakeholder engagement web conference will help inform the discussions of the EWG as the group works on developing a responsive updated guideline. Members of the EWG will provide an overview of the ongoing work to update the guideline and will subsequently hear presentations 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 question 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 see the ICH E6(R3) Concept Paper and other materials at www.ich.org. Meeting details are available on FDA’s website.
Webinar Now Available: Findings & Reflections from CTTI’s ICH E6 Renovation Work
A recording is now available of a CTTI webinar on new stakeholder-informed research to identify areas within ICH E6 GCP that are in the greatest need of renovation. The webinar, held Thurs., March 19, included several perspectives about how this research could further the international conversation about ICH E6 GCP:
- Celia Witten (FDA, CBER)
- Amy Corneli (CTTI)
- Dagmar Gortz (Janssen)
- Pamela Gonzalez (University of Chicago)
Witten provided an overview of the ICH revision processes and expected timelines as well as the guiding principles behind the effort. She said that the knowledge gained by learning from stakeholder experience and viewpoints will further enrich ongoing expert working group discussions. “It’s quite valuable to us and lights the way to highlight certain areas that need more attention,” said Witten.
Corneli provided an overview of the research methodology and findings. She highlighted the three modes of the project: an online survey; qualitative, in-depth telephone interviews; and an open-comment platform. The research included the perspectives of more than 300 research professionals in 20 different global regions.
One of the key themes that stakeholders identified was that researchers need flexibility depending on the type of research being conducted and simplification of guidelines so that more investigators adhere to them. Transparency in the transition process and ensuring that a variety of stakeholders guide the process were also identified as priorities.
Gonzalez provided her thoughts on the research from the academic clinical site perspective. “The themes and the results of the survey are aligned with my own thoughts. There is a need for more flexibility. We need to have better alignment with the risk in protocols,” she said.
Gortz spoke through the lens of her industry role. She emphasized the need for case examples that could help illustrate how to use guidelines. “I was pleased to see the strong desire and strong ask for stakeholder engagement in the revision process for the guidelines,” she said.
Explore this research further by reading our executive summary, interview findings, survey findings, and open comment findings.
Webinar to Provide Findings & Reflections from CTTI’s ICH E6 Renovation Work
As the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) begins revisions to ICH E6 GCP, new CTTI research highlights opportunities for changes and improvements.
CTTI will host a webinar Thurs., March 19, at noon ET providing an overview of new multi-method research to identify areas within ICH E6 GCP that are in the greatest need of renovation. Speakers will include:
- Fergus Sweeney (EMA)
- Celia Witten (FDA, CBER)
- Amy Corneli (CTTI)
- Dagmar Gortz (Janssen)
- Pamela Gonzalez (University of Chicago)
CTTI’s research includes the perspectives of more than 350 research professionals in 20 different global regions and describes stakeholder experiences with implementing ICH E6 GCP. Preliminary findings were presented to the FDA and EMA in advance of the first ICH E6 work group meeting in November 2019. Some of the initial findings include:
- 32.4 percent of respondents use mobile applications for the remote capture of efficacy or safety outcomes data for regulatory decision making
- 62.1 percent use routine health care data for capture of efficacy or safety outcomes data for regulatory decision making
- 60-75 percent of survey respondents indicated that renovation is not needed to the general principles
- Areas identified as needing the most renovation included: Sponsor, Essential Documents, and Investigator. Of less need for renovation were topics in the section on Clinical Trial Protocol and Protocol Amendments.
To hear more, mark your calendar for the upcoming webinar today!
New Paper Offers Recommendations for Efficient Identification and Training of Investigators
CTTI has released a new preprint paper describing its recommended approach for identifying and preparing investigators and their delegates to perform clinical research. The paper suggests that by moving beyond Good Clinical Practice (GCP) training as a one-size-fits-all solution, sponsors, CROs, investigators, and other research professionals may be able to more efficiently find and train investigators for quality research.
Specifically, CTTI recommends complementing previous GCP training with a fit-for-purpose, risk-based training approach to close identified gaps in knowledge or skills. This multifaceted approach to training can enrich understanding of how GCP principles apply to the conduct of a particular clinical trial and help investigators grasp how to better apply quality principles in a specific setting. Combining the real-world application of GCP principles with role- and protocol-specific instruction has the potential to add greater value to the investigator qualification process, leading to the higher quality conduct of trials.
CTTI used findings from qualitative research with investigators and clinical trial sponsors, along with input from an expert meeting with multiple stakeholders, to develop the recommendations. The research identified gaps and redundancies in the current training of investigators and their delegates, as well as a common theme: the didactic, one-size-fits-all approach most commonly used for training investigators and documenting their qualification often introduces redundancies and minimizes the value of previous training.
In the paper, CTTI offers detailed recommendations for how sponsors, CROs, and site teams can respond to these insights and positively shift the investigator training culture, as well as further discussion of how a targeted learning approach can better prepare investigators and their delegates to conduct quality clinical trials.