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 One particularly interesting statement in the draft guidance says, “Create a culture that values and rewards critical thinking and open dialogue about quality and that goes beyond sole reliance on tools and checklists”.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.
- The Clinical Pathways Team
Enjoy this blog? Please like, comment, and share with your contacts.