Ready to Elevate Clinical Trials with ICH E6 R3 and Quality-by-Design!

Just returned from #SCOPE2023. More and more insights have become available about approaching ICH GCP E6 R3, which I am happy to share with the clinical research community.

ICH is currently working on the development of the third version of its critical guideline, ICH E6 Good Clinical Practice (GCP). This updated version, ICH E6 R3, will reflect the latest advancements in technology and innovative clinical trial designs while maintaining its commitment to protecting human participants and ensuring reliable evidence generation.

The ICH community is actively engaged in evaluating new topics and revising existing guidelines, and this process includes opportunities for public input and stakeholder engagement. The ICH management committee has already made the work-in-progress draft version of the principles for ICH E6 R3 public, and further engagement with academic experts and the wider public will continue as the guideline evolves.

This document focuses on the importance of quality by design in clinical trials.

Quality-by-design sets out to ensure that the quality of a trial is driven proactively by designing quality into the study protocol and processes.

This may involve the use of a prospective, multidisciplinary approach to promote the quality of protocol and process design and clear communication of how this will be achieved.

Quality by design approaches should be applied across the clinical trial and supporting processes.

Moreover, risk-based approaches should be considered when implementing proportionate measures to ensure GMP and the appropriate shipping and handling of the investigational product.

Stay tuned for the release of ICH E6 R3, and let's work together to bring the best quality to our clinical trials!

#QualitybyDesign #ClinicalTrials"