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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 summaryinterview findings, survey findings, and open comment findings.