International Council for Harmonisation Reflection on “Good Clinical Practice Renovation“

On 12 January, the International Council for Harmonisation (ICH) published a press release about its reflection paper on Good Clinical Practice (GCP) “Renovation”. ICH is inviting public review and comment on this paper, which contains the ICH proposal for further modernisation of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The scope of the proposed renovation includes the current E8 General Considerations for Clinical Trials and further revision to the E6 Guideline for Good Clinical Practice, which is already undergoing modernisation with the recent production of ICH E6(R2).

With this paper, ICH is following the demand for a more holistic approach of planning and conduct of clinical trials and also realising the shift to leverage the large amounts of available data from the “real world” (e.g., electronic health records, hospital discharge summaries, claims data, patient/disease registries, etc.). Details of the proposed “Renovation” are outlined in the reflection paper.


Tagged with

Published on 18. January 2017 in News EU