Part 2 of this series summarized the background and need for the upcoming updates to ICH E6 and ICH E8 per the ICH’s reflection paper that is currently available here and is open to stakeholder comment until March 27th. Section 2 of the reflection paper “Proposed Structure for a Modernized ICH E8 Guideline and a Future Renovated ICH E6 Guideline” focuses on ICH E8 explaining the need for modernization:
Proposed ICH E8 updates would include:
- Identify aspects of a trial that are critical to generating reliable data.
- Include strategies and actions that could effectively and efficiently support quality in critical areas.
The identification of relevant critical-to-quality (CTQ) factors could be clarified in this guideline to be explicitly addressed in risk-based management and monitoring procedures in short “ICH is proposing a modernization of ICH E8 in order to incorporate the most current concepts achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials”.
Proposed ICH E6 updates would include:
- Reference to ICH E8 to ensure high-quality data is obtained from a protocol designed to reflect focus on “quality by design” along with other comprehensive relevant ICH guidelines that reinforce the concept.
- Transformation of the ICH E6 body to include overarching human subject protection and data quality principles to further recognize that trial design and study objectives influence the criticality of different factors such as using a risk-based approach to study oversight and monitoring.
- Develop a set of annexes that apply the principles outlined in the main body of ICH E6 providing a practical framework for different types of studies. Proposed annexes are:
- Annex 1: Traditional Interventional Trials of Investigational unapproved or approved drugs.
- Annex 2: Non-traditional Interventional Trials and/or data sources.
- Annex 3: Non-Traditional Trial Designs
Coming up in the last part of the series, Part 4 covers the proposed plan and timeline for renovation work of ICH E6 and ICH E8.
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-The Clinical Pathways Team