Are you ready for ICH E6 (R3)?
The International Council for Harmonisation (ICH) is looking to finalize new guidelines in 2025 with more detailed requirements and updated responsibilities for Sponsors, Sites, and Investigators. ICH E 6(R3) emphasizes a more risk-based approach; this may create a need for investment in new technologies or systems to effectively manage new processes. It also may require a more holistic approach using quality by design (QbD) to ensure that design elements incorporate quality assurance throughout the entire process.
ICH E6 (R3) Annex 2 was endorsed on November 06, 2024. Major changes to be considered include a renewed focus on the use of Real World Data (RWD), as well as using decentralized elements and digital health technologies (DHTs). Guidance for incorporating RWD into clinical trials includes utilizing patient health status collected from a variety of sources outside of clinical trials (e.g., electronic health records (EHRs), registries, claims data, etc.)
ICH E6 (R3) is being designed to address the future with a goal of implementing strategies to make trials less rigid while at the same time incorporating quality from the start. Professionals that work in clinical trials can become familiar with coming changes by reviewing new guidelines before jumping in and trying to tackle all changes at once. Sponsors, CROs, and Investigators can review ICH E6 (R3) and many more guidelines at the official ICH website. Change is hard. But being prepared is a great strategy for meeting the challenges posed by revised guidelines. If you need help, contact our team at QualMedica Clinical Consulting.
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