Summary of Stakeholder Engagement to Support the Development of ICH E6(R3)

On 18 May 2020 the ICH announced the availability of the summary of the E6(3) stakeholder engagement approach.

The ICH-E6 GCP guideline is the reference standard for the conduct of clinical trials at a global level, including for non-traditional trial types, such as adaptive trials, trials utilizing master protocols, decentralized clinical trials and others in a clinical environment that is drawing on ever increasing data sources enabled by digitalisation of processes and information. In addition, while ICH-E6 is intended as a guidance for clinical trials that support regulatory submission of drugs, it may be applied to clinical trials in general. Patients, academic clinical researchers, and other stakeholders can provide unique and important insights into the design and conduct of clinical trials, as well as the ethical considerations that should be addressed.

ICH committed to stakeholder engagement with academic clinical researchers and patient representatives in its Reflection paper on Renovation of Good Clinical Practice and in the Concept Paper for the revision of ICH-E6. Understanding these groups’ perspectives as the working group develops ICH-E6(R3) will help to ensure that the guidelines are responsive to the needs of those conducting or participating in clinical trials. ICH considers the benefits from these engagements to be substantial and worth the effort and time to organise them.

Read the pdf 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /