The SCTO Forum 2025 took place on Wednesday, 29 January 2025, in Bern, bringing together 77 key participants to explore the latest updates to the ICH-GCP E6(R3) guidelines. These revisions aim to modernise and improve clinical trial practices worldwide.

The updates focus on enhancing flexibility, efficiency, and data integrity, responding to evolving trial designs and technological advancements. Expert speakers provided in-depth insights into the ICH GCP E6(R3) revision, discussing its rationale, public consultation feedback, and the main themes raised by stakeholders.

Presentation topics included:

• ICH GCP E6(R3) Revision: Rationale, Expectations and Annex II
• General impacts of the revision for Switzerland
• Quality by design
• Exploring Annex II: Real-World Evidence and Its Impact on Clinical Trials

Following each presentation, a Q&A session sparked engaging discussions among participants.

Key takeaways from the Forum:

• Ongoing reflection and critical thinking are essential — understanding when and why decisions are made, while balancing benefits and risks.
• Researchers will need to engage not only with GCP E6, but also with E8, which regulates studies outside of clinical studies.
• The revisions are benefical and there is ample time to prepare in advance.
• Terms like "pragmatic" and "real-world" are used frequently, but their precise meaning must be carefully considered.

Download the presentations of the SCTO Forum 2025 below and learn more about the new ICH GCP E6(R3).

Each year, the SCTO invites experts and guests from all over Switzerland and from abroad to its SCTO Forum. The aim of the Forum is to foster discussions on emerging topics that have the potential to change the way we do clinical research in practice. At a minimum, these discussions should raise awareness of upcoming changes; ideally, they also result in recommendations on how to best address these changes.