The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is revising the ICH GCP Guidelines ICH E6(R3) to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of study types and data sources being employed to support regulatory and other health policy decisions. Based on previous experience [e.g., ICH E8(R1), ICH E6(R2)], it is expected that following the release of the final revisions (including Health Authority implementation), key stakeholders of clinical trials will face challenges in operationalizing some of the requirements in the guidelines given uncertainty in interpretation and inter-relatedness of the guidance.
To address these challenges, this initiative is developing solutions that aid in understanding and interpreting the more ambiguous aspects of the guidelines, which will help accelerate knowledge management within the clinical research ecosystem. The approach is to deliver solutions developed through collaboration and stakeholder engagement across six focus areas of ICH E6(R3). Of the six areas, TransCelerate is partnering with the Association of Clinical Research Organizations (ACRO) to co-develop solutions within two focus areas, risk management and data governance. In addition, we are exploring ways to engage with clinical site stakeholders to develop a solution to help sites manage the implementation of ICH E6(R3).
Trial Design
Additional resources and solutions coming soon in 2024 and early 2025.
Risk Proportionality
Additional resources and solutions coming soon in 2024 and early 2025.
Risk Management
Focus Area Overview and Objective
TransCelerate has been working with ACRO to co-develop a “Risk Management Toolkit”, which is designed to facilitate the industry’s comprehension and application of changes in risk management, particularly with the transition from ICH E6(R2) to E6(R3). It will provide a suite of resources, including delivered solutions, such as a comparison of ICH E6(R2) and E6(R3) and control strategy considerations, and forthcoming deliverables, such as an anticipated quality management solution. The toolkit will serve as a guide to identify opportunities and challenges, highlight critical changes, and integrate risk management within the framework of ICH E8(R1) principles, such as quality by design and fit-for-purpose. TransCelerate’s work with ACRO supports the industry’s ongoing commitment to the core principles of Good Clinical Practice (GCP) by evolving existing tools and solutions, addressing known areas of improvement, and offering in-depth information for thoughtful consideration during the adoption of ICH E6(R3).
Deliverables
Key Risk Management Changes in Good Clinical Practice [ICH E6(R3)] – Infographic (Co-developed with ACRO)
An infographic that highlights key changes to the risk management elements within Good Clinical Practice Version 2 and 3. Co-developed with ACRO, this infographic aims to allow industry to easily identify the impact to their process and how to react for efficient ICH E6(R3) implementation. Based on Version 3 (draft dated 19 May 2023).
Control Strategies and Good Clinical Practice (ICH E6(R3)) (Co-developed with ACRO)
A considerations tool, co-developed with ACRO, to support the implementation of control strategies under ICH E6(R3) guideline. Application of ICH E6(R3), specifically control strategies in clinical trials, ensure protection of the rights, safety, and well-being of participants and enhance the reliability of study results. Based on Version 3 (draft dated 19 May 2023).
Data Governance
Additional resources and solutions coming soon in 2024 and early 2025.
Monitoring
Additional resources and solutions coming soon in 2024 and early 2025.
Investigators
Additional resources and solutions coming soon in 2024 and early 2025.