On October 31, 2025, Swissmedic and swissethics announced an update to their position paper on decentralised clinical trials (DCTs) for medicinal products. The document, now available as version 3.3, introduces important revisions aimed at enhancing clarity and aligning protocols with evolving regulatory and technological landscapes. These changes are crucial for clinical, quality, and regulatory teams navigating DCT frameworks in Switzerland.
What Changed?
The updated position paper, available as version 3.3, reflects adjustments tailored to ongoing advancements in technology and evolving clinical trial methodologies. Key updates include expanded guidance on digital tools for remote patient monitoring, revised recommendations for informed consent processes within decentralised trial settings, and clarified roles for sponsors, investigators, and other stakeholders.
Through these revisions, Swissmedic and swissethics aim to ensure that DCTs uphold the highest standards for safety, data integrity, and ethical practices while accommodating emerging technologies.
Who Is Affected?
The changes impact all stakeholders involved in DCTs within Switzerland. This includes clinical teams, regulatory affairs professionals, and developers of medical devices or digital health solutions integrated in such trials. Sponsors and investigators should pay close attention to how the updates influence their trial designs and operations, particularly regarding patient recruitment, monitoring, and data collection.
Key affected groups include:
- Clinical research organizations (CROs) implementing trials using decentralised processes
- Sponsors navigating regulatory approvals for DCTs in Switzerland
- Quality assurance representatives addressing compliance
Guidance for Implementation
How to Apply the New Recommendations?
Swissmedic encourages stakeholders to integrate the revised position paper’s guidelines into ongoing and future projects. Sponsors should evaluate whether their current protocols align with the updated criteria for digital tools, patient engagement, and data validation.
Key Considerations
- Ensure GDPR compliance when implementing remote monitoring technologies in trials.
- Review roles and responsibilities to confirm adherence to Swissmedic’s clarified requirements for investigators and sponsors.
- Update informed consent materials to reflect best practices for DCT settings.
The document serves as a cornerstone for the safe, ethical, and efficient operation of decentralised trials.
FAQ
Q1: What is a decentralised clinical trial?
A decentralised clinical trial (DCT) involves conducting trial activities partially or fully outside traditional clinical sites using digital technology and remote monitoring techniques.
Q2: Are sponsors obligated to apply the new guidance?
Sponsors conducting trials within Switzerland must adhere to these updated standards to ensure compliance and ethical operation of DCTs.
Q3: Where can I access version 3.3 of the position paper?
Version 3.3 is available on the Swissmedic website under their clinical trials publications section.
Conclusion
The revised position paper by Swissmedic and swissethics holds substantial implications for decentralised clinical trials conducted in Switzerland. From updated digital tool guidance to expanded roles for stakeholders in trial operations, the changes strengthen patient safety and data quality for current and future studies.
Clinical, quality, and regulatory teams are urged to review the new recommendations promptly, aligning their processes with version 3.3’s directives.
Disclaimer
This article provides general information and is not legal or regulatory advice. Please review official guidelines or consult regulatory experts for specific concerns.
Swissmedic Announcement
For full information about the Swissmedic announcement, see the link below.