Comment Now! FDA Releases Draft Guidance E8 Revision



The Food and Drug Administration (FDA) announced the availability of the draft guidance “E8(R1) General Considerations for Clinical Studies” for public comment. The purpose of the draft guidance is to increase flexibility of clinical trials while improving the quality of clinical trial data presented to regulatory authorities. The draft guidance originates from the International Council for Harmonisation’s (ICH) E8 draft revision. The revision is part of ICH’s Good Clinical Practice (GCP) Renovation initiative, which outlines plans to revise ICH E8 and further revise ICH E6. Previously, the ICH E6 R2 addendum was finalized in 2016.

Key updates in the draft guidance are: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The draft guidance has a greater emphasis on patient centricity, design of trials with quality in mind, and risk management.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. Identifying critical to quality elements or risks requires critical thinking skills and communication among stakeholders.


Comment now through September 30, 2019 here.

Please reference our companion blogs about: critical thinking in clinical research or the open comment period for ICH E8 draft revision. You may also enjoy 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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