E6(R3): ICH releases draft of overhauled GCP guideline for consultation
The International Council for Harmonisation (ICH) on Tuesday published the long-awaited draft version of its ICH E6(R3) guideline on good clinical practice (GCP) for consultation by its regulatory members. Alongside the draft guideline, ICH announced it has begun work on a second annex to the document, following the adoption of an Annex 2 concept paper by its management committee earlier this month.The third revision of the seminal international GCP guideline kicked off in 2019, three years after the international harmonization body adopted the current version of the guideline, E6(R2), which added an integrated addendum to the document focused on efficient trial design, conduct, oversight and reporting. While the R2 version was developed to account for emerging technologies and electronic data sources, ICH felt the need to update the document to further address innovative trial designs, diverse data sources and to align the guideline with its recent E8(R1) General Considerations for Clinical Studies.
“Since the development of E6(R2), clinical trials have continued to evolve with new designs and technological innovations. It was also noted that while E6(R2) provided a great deal of details, it did not address many aspects of modern clinical trials,” ICH said. “Advances in technologies used in clinical practice provide opportunities to integrate clinical research and clinical care. The trend of growing interoperability of technology across the data life cycle serves as a new vehicle for data exchange among multiple stakeholders in the clinical trial enterprise, including patients, researchers, and caregivers. The richness of these multiple data sources and the growing exploration and use of artificial intelligence offers the potential to significantly enhance evidence generation in clinical trials.”
The draft document lays out the principles of GCP for clinical trials of investigational products and includes the Annex 1, which focuses on interventional clinical trials. Annex 2, when completed, will provide additional considerations for “non-traditional” interventional clinical trials, which include pragmatic and decentralized studies, as well as studies involving the use of real-world data.
Development on Annex 2 is just getting underway and will continue in parallel with the feedback process for the E6(R3) principles and Annex 1 components. ICH said it expects a draft of Annex 2 to be ready in 12-18 months.
In anticipation of an “extraordinarily large number of comments,” ICH asked that stakeholders prioritize or highlight their key comments, link their comments to line numbers in the draft documents, offer justifications and examples to support any requested changes and that organizations consolidate their comments.
While ICH is open to input across the range of topics found in the guideline, it specifically asks for comments on areas that may require more clarity, areas of the guidance that are not hospitable to technological and design innovations, as well as input on training components that should be developed alongside the guideline.
ICH, E6(R3) draft guideline
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