ICH E6 (R3) Good Clinical Practice: What is it and What is the Impact to Imaging Trials?

Overview: Imaging Endpoints (IE) has established a strong reputation for quality through a perfect inspection record and remarkable marketing authorization success rate and is expanding its quality leadership by integrating the new standards of ICH E6 (R3) into IE’s Quality Management System. ICH E6 (R3) Good Clinical Practice is a global standard for the conduct of clinical trials. It is the third revision of the standard, developed to refine GCP concepts and to align with other essential standards such as ICH E8 General Considerations for Clinical Trials, while providing a roadmap to the modernization of good clinical trial practices.

Background: ICH E6 (R3) represents an update to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, specifically focusing on Good Clinical Practice (GCP) standards. A draft Guidance was issued for ICH E6 (R3) in May 2023 and Annex 1 covering Interventional Clinical Trials is expected to be adopted in October 2024, with Annex 2 to be adopted in April 2025.

ICH E6 (R3) introduces several notable updates and enhancements compared to its predecessor. These include a stronger emphasis on risk-based approaches to trial management, increased requirements for sponsor oversight and accountability, and expanded guidance on electronic trial documentation and data integrity. Additionally, ICH E6 (R3) places greater emphasis on the importance of incorporating patient perspectives into trial design and execution, reflecting a broader recognition of the significance of patient-centricity in clinical research. Overall, the revisions in ICH E6 (R3) represent a comprehensive effort to modernize and improve GCP standards, aligning them more closely with contemporary practices while advancing the quality and efficiency of clinical trials.

Now with this general understanding, what is the impact to imaging services in clinical trials?

Focus: In adopting new quality standards, Imaging Endpoints first establishes a roadmap by determining what GCP requirements are applicable to Blinded Independent Central Review (BICR) for trial imaging, and then develops GCP strategies focused on the requirements. Additionally, we work to align the GCP standard as an extension of concepts within our QMS derived from ICH E8 (R1) General Considerations for Clinical Studies.

The implementation of ICH E6 (R3) is likely to have several implications for central imaging assessments conducted by Imaging CROs. First, with its emphasis on risk-based approaches to trial management, IE has been adopting more robust risk assessment strategies tailored to imaging endpoints such as identifying potential risks associated with imaging data collection, analysis, and interpretation, and implementing measures to mitigate these risks effectively.

Furthermore, the increased requirements in ICH E6 (R3) for sponsor oversight and accountability are leading to closer collaboration and communication between sponsors and all their vendors for clinical trials. Imaging Endpoints is working more closely with Sponsors on comprehensive reporting and documentation to ensure enhanced transparency regarding imaging data quality, deviations, and regulatory compliance measures.

Additionally, the expanded guidance on electronic trial documentation and data integrity in ICH E6 (R3) favors Imaging CROs such as IE with advanced imaging technologies and digital platforms to support data management and documentation processes. Ensuring the integrity, security, and traceability of electronic imaging data is paramount, requiring robust data management systems and adherence to stringent data protection protocols.

Close: Overall, the implementation of ICH E6 (R3) is likely to elevate the standards and expectations surrounding central imaging assessments in clinical trials. Imaging Endpoints is enhancing risk management practices, strengthening sponsor relationships, and embracing digital innovation to ensure our leadership growth in compliance and data integrity.

Next: In upcoming posts, we will delve deeper into the core concepts pivotal to imaging services, emphasizing our proactive initiatives to surpass the benchmarks set by ICH E6 (R3). We will explore:

• Quality by Design (QbD): Revolutionizing how quality integrates into the imaging design phase of clinical trials, ensuring stringent adherence to study requirements and safeguarding data integrity from inception.
• Risk-Based Quality Management (RBQM): Employing a risk-based approach to quality management, identifying, assessing, and controlling risks at all levels of trial operation to ensure participant safety and result reliability.
• Critical-to-Quality Factors: Prioritizing factors critical to trial quality, maintaining them within optimal ranges, and vigilantly monitoring them throughout the trial duration.
• Data Governance: Unpacking this novel section of the standard and its relevance to imaging trials, focusing on managing data integrity, security, and delivering accurate, comprehensive results crucial for marketing authorization of essential therapies.

We’ll illustrate how Imaging Endpoints sets industry standards by seamlessly integrating GCP responsibilities with our unparalleled imaging science expertise, resulting in an exemplary inspection record and a globally unmatched success rate in securing marketing authorizations.

To arrange a conversation with our Compliance and Regulatory experts