The Cancer Drug Development Forum – CDDF is the platform for all stakeholders involved in the development of cancer drugs.

We are pleased to announce that the ICH E6(R3) principles and Annex 1 have been finalised and published on the ICH website. This is a rewrite and reorganisation of the R2 version of the guideline on Good Clinical Practice (GCP), which sets international standards for clinical trials involving human participants.

This marks a milestone of the work started five years ago by the ICH E6(R3) Expert Working Group. The update aims to apply GCP principles to the increasingly diverse trial types and data sources supporting regulatory and healthcare related decision-making on medicines, and provide flexibility, where appropriate, to facilitate the use of technological innovations in clinical trials.

To ensure the guideline addresses the needs of all stakeholders, it takes into account feedback received through an extensive public consultation of the draft text and other channels, including a dedicated Accelerating Clinical Trials in the EU (ACT EU) public workshop in 2023.

To support stakeholders in the implementation of the revised guideline, the ACT EU initiative is organising a public workshop on the ICH E6 R3 revision on 19-20 February 2025.

Annex 2 of the guideline is being developed in parallel. It provides additional GCP considerations focusing on examples of trials that incorporate decentralised elements, pragmatic elements and/or real-world data. A draft of Annex 2 is currently under public consultation, concluding on 28 February 2025.

Cancer Drug Development Forum asbl
Registered office: c/o BLSI, Clos Chapelle-aux-Champs 30, 1200 Woluwe Saint Lambert, Belgium
Register of legal entities: the French Speaking Enterprise Court in Brussels
Enterprise number: 738.523.752

Privacy Policy

info@cddf.org
Tel: +32 2 880 62 70