ICH E8(R1) General Considerations for Clinical Studies – Three Key Concepts

The new version of E8 has now been finalised and this brief blog post will summarise three of the key shifts in focus for the future of clinical trials.


  1. Participants not subjects

In line with the proposed changes to ICH E6 one of the fundamental shifts in the guidance is the change in attitude to the people who take part in clinical research.  The change of name from subject to participant is illustrative of this, but more important is the call to consult with patients early on in clinical study design and to include them as key stakeholders in the clinical trial process.


  1. Quality by Design

This new buzz term describes an approach to clinical development which puts the quality of the research at the forefront to improve the likelihood that the research will answer appropriate questions while preventing important errors. Some of the main elements of Quality by Design are:

  • clear pre-defined study objectives that address the primary scientific question(s);
  • selection of appropriate participants;
  • use of approaches to minimise bias, and/or control of confounding;
  • endpoints that are well-defined, measurable, clinically meaningful, and relevant to patients.


  1. Critical to Quality Factors

This is another new buzz term which supplements the Quality by Design concept by considering design and operational factors which impact on quality and ultimately the ability of the study to answer the research question(s) effectively.

The steps to achieve this are:

  • Establishing a culture which supports open dialogue
  • Focusing on activities essential to the study
  • Engaging stakeholders in study design (including patients)
  • Reviewing Critical to Quality Factors as a basis for Risk Based Quality Management
  • Critical to Quality Factors in Operational Practice – including feasibility assessment


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