“GCP Renovation” for the Modernization of ICH E8 and Subsequent Renovation of ICH E6! Series Part 1/4


The International Council for Harmonisation (ICH) is inviting public review and comment on a recently released reflection paper on ICH E6 and ICH E8 renovation and modernization available here. ICH seeks to develop clear guidelines that are “both appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources that are being employed to support regulatory and other health policy decisions” while continuing to ensure the human protection and high quality data principles.

The targeted revisions of the current guidelines seek to:

  • ICH E8:
    • Emphasize “critical to quality factors that should be considered by sponsors when planning a study”.
    • Set a standard of “quality by design” QbD for new trials.
    • Provide a comprehensive reference for all other relevant ICH guidelines necessary for study design and/or conduct.
  • ICH E6:
    • Recognize and address procedures for studies keeping in mind the levels of risk for participants i.e. treatment vs. non-treatment studies.
    • Expand the limited scope of the current GCP guideline to address a broader range of study types and data sources.
    • Clarify procedures to apply a “risk-based approach to site monitoring”.

This is Part 1 of 4 of Clinical Pathways ICH modernization and renovation series; Part 2 addresses the background leading to and supporting the changes; Part 3 evaluates the proposed structure of the upcoming changes, and Part 4 summarizes the working group implementation steps.

Remember that stakeholders are invited to submit any comments for the reflection paper to gcprenovation@ich.org. All comments should be submitted before the closing date for public comment, which is March 11, 2017.

For more information, contact SAM at samsather@clinicalpathwaysresearch.com or laidy@clinicalpathwaysresearch.com.

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