I had the pleasure of participating in the ACT EU workshop on ICH E6(R3) at the European Medicines Agency (EMA) on the19th and 20th of February. It was great to see such a broad range of stakeholders—including inspectors, experts from the ICH E6(R3) Expert Working Group (EWG), patient associations, contract research organizations (CROs) and industry representatives—gathered together to share the latest insights on this evolving guidance.
ICH E6 (R3) Updates: Key Takeaways from the ACT EU Workshop
The Importance of Gap Analysis and a Risk-Based Approach
The workshop was filled with engaging discussions, thought-provoking insights, and plenty of “aha” moments. One of the key takeaways was the recommendation for sponsors to perform a gap analysis in order to assess training needs related to the updated ICH E6(R3) guidance and to identify areas that needs to be implemented and/or improved. This would make a risk-based approach the foundation for sponsors to incorporate into their clinical trial processes and was one of the recommendations included in my webinar held on the 12th of December 2024, Inspection Readiness and the Updated ICHE6R3: What to Anticipate.
Patient Perspectives: A Critical Part of the Conversation
The input from patient associations was very interesting and thought provoking in many ways. By giving insights in clinical trial procedures and informed consent, discussions clearly highlighted the importance of a risk-proportionate approach. It became evident that patients’ voices need to be integrated into the clinical research landscape, as their perspectives will be invaluable in shaping the revised guidance.
Embedding Quality by Design into Clinical Trials
Another recurring theme brought up repeatedly during the workshop, was the emphasis on risk-based approaches, quality by design (QbD), and critical-to-quality (CtQ) factors. These concepts aren’t just buzzwords—they reflect a real paradigm shift towards a quality culture in clinical trials, aiming to embed quality into each step of the clinical trial lifecycle. The discussions reinforced that sponsors must prioritize identifying and managing critical-to-quality factors to ensure trial success.
Risk Management and “Fit-for-Purpose” Strategies
The evaluation of risk management strategies in clinical trials and whether they are truly “fit for purpose” was a particularly engaging topic. The experts agreed that inspectors would rely on auditors to determine whether risk management approaches are working as intended—with a “fit for purpose” strategy—and make adjustments if necessary.
Data Governance and the Role of Electronic Medical Records (EMRs)
Data governance was another important topic on the agenda, stressing the need to clearly define and document responsibilities for computerized systems used by both the sponsor and investigator. Sponsors are responsible to ensure that their system is fit for purpose and that expectations outlined in the guidance are proportionate to the trial’s needs.
However, the discussion also raised important concerns about unvalidated electronic medical records (EMRs) used in clinical trials. Stakeholders align on the conclusion that printing medical records as a risk mitigation strategy is no longer acceptable. Inspectors noted that the printed records often do not match what was originally entered in the electronic system. Therefore, institutions and investigators must carefully evaluate whether their systems adequately support source documentation in clinical trials.
Shaping the Future of Clinical Trial Guidance with ICH E6(R3)
The workshop represented an important step toward modernizing clinical trials. Through the collaborative work among all stakeholders, we aim to provide the definitive guidance that is not only fit for purpose but also aligned with the evolving clinical research landscape. Moving forward, integrating patient perspectives and cultivating a quality culture will be critical in shaping the future of clinical trials.
For further details and insights on the changes in ICH E6(R3), read my recent blog Revision of ICH E6(R3): A New Chapter for Clinical Trials and Their Stakeholders . At Allucent, we are here to assist you with every aspect of GxP compliance and to support your drug development program. Explore our comprehensive offerings on GxP compliance and inspection readiness.
About the Author
Ernesto Vera-Sanchez, MD, PhD, MPH, Vice President, Department Head of GxP Strategy at Allucent, has nearly 20 years of experience as a regulator and an EMA & AEMPS GXP Inspector. His comprehensive knowledge of clinical trial regulations and guidance from EMA/FDA/MHRA/PMDA, as well as his extensive experience in inspection strategy and related procedures, lend to his wide-ranging expertise. Dr. Ernesto has led over 400 regulatory inspections at clinical investigator sites, CROs, sponsors and vendors.
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