On 19 April 2021, the ICH E6 working group shared a work-in-progress version of updated principles for E6. This is an early look at the first work product for the E6(R3) guideline.
What is ICH E6(R3)?
The International Council for Harmonisation (ICH) E6(R2) guideline for good clinical practice (GCP) is the current global standard for clinical trials. However, the ICH currently has a working group tasked with revising it (referred to as “R3” as it is the third revision). When finished, the updated ICH E6(R3) will include an overarching principles document, and two Annexes, with the plan that the principles document and Annex 1 will replace the current ICH E6(R2) guideline.
Overview of ICH E6(R3) Draft Principles
The draft principles document proposes an expansion of the current ten principles to twelve. None of the previous ten principles were removed, however the numbering and organization changed. A lot of the added text is information that was previously in the ICH E6(R2) guideline, just in different sections.
The draft principles include new considerations that relate to emerging themes in clinical research, such as:
- Including quality by design in every part of the research, especially factors critical to the quality
- Ensuring informed consent is understandable to subjects
- Emphasizing importance of diverse and representative subject populations
- Understanding that clinical research includes many parties (such as physicians, scientists, ethicists, technology experts, and statisticians) not just researchers and sponsors
- Acknowledging data protection and privacy as fundamental to subject protection
- Focusing on operational aspects of clinical trials
- Ensuring that clinical trials generate reliable results
New Principles Added
There were new principles added in the draft principles document. These principles all include subpoints in the draft document, but for conciseness they are presented below as the main points. The new principles include:
- Quality should be built into the scientific and operational design and conduct of clinical trials.
- Clinical trial processes, measures, and approaches should be proportionate to the risks to participants and to the reliability of trial results.
- Clinical trials should be described in a clear, concise, and operationally feasible protocol.
- Clinical trials should generate reliable results.
- Roles, tasks and responsibilities in clinical trials should be clear and documented appropriately.
- Investigational products used in a clinical trial should be manufactured in accordance with applicable Good Manufacturing Practice (GMP) standards and be stored, shipped, and handled in accordance with the product specifications and the trial protocol.