ICH Releases E8 “General Considerations for Clinical Trials” Draft Revision for Public Comment


Image by  Gerd Altmann  from  Pixabay

Image by Gerd Altmann from Pixabay

Clinical trials have become increasingly complex since the ICH E8 guideline on “General Considerations for Clinical Trials” was finalized in 1997. The draft revision is in Step 2b and available for public comment, and there are some interesting changes to note. Specifically, there is a greater emphasis on patient centricity, design of trials with quality in mind, and risk management. The overlying theme is fit-for-purpose quality as an essential consideration for study design. The revision is part of the Good Clinical Practice (GCP) Renovation initiative. Previously, the ICH E6 GCP R2 addendum was finalized in 2016.

Key updates in the draft revision are:

  • New objective relating to quality in the design and conduct of the clinical trial

  • Additional section about patient centricity in the study design which would:

    • Promote confidence in the study

    • Discover endpoints that meaningful

    • Support the development of treatments that are meaningful to actual patients

  • New section on quality includes the importance of:

    • Identifying a set of factors critical to quality and risks that would threaten quality

      • Quality is based on good study design and execution

      • Quality studies protect subjects, ensure integrity of data, and manage risks

    • Customizing the design based on the specific needs for each trial

    • Determining if impacts are acceptable or how to mitigate risks

    • Focusing efforts on elements that are essential to subject protection and outcomes that are meaningful to the subjects

    • Seeking stakeholders’ input to inform study design

    • Reviewing and modifying identified risks and risk management

  • Expanded section on drug development by splitting it into three sections: 1) drug development planning, 2) design elements, and 3) conduct and reporting

  • Added a section listing potential considerations for identification of critical to quality factors

  • Updated the annex to add types of studies and their objectives with examples

The draft revision focuses on the need to identify critical to quality elements and highlights that other ICH guidelines should be consulted. There is a reference table in the annex mapping critical to quality elements to relevant guidelines. One particularly interesting statement in the draft guidance says, “Create a culture that values and rewards critical thinking and open dialogue about quality and that goes beyond sole reliance on tools and checklists”. (ICH E8 (R1) 3.3.1). Identifying critical to quality elements or risks requires critical thinking skills and communication among stakeholders. Public comment is welcome through October, and the goal is to release the revised guideline in June 2020.

You may also enjoy our companion blog about critical thinking in clinical research or our interactive eLearning courses: ICH E6(R2) GCP or our critical thinking course the DIGR-ACT® Solution.


- The Clinical Pathways Team

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