Hybrid Trials and the EU AI Act: Merging Tradition with Technology
Atlantia Clinical Trials
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Overview:
Clinical trials have transformed over the years, and the debate between fully remote and hybrid trial models is more relevant than ever, especially with the implementation of the EU AI Act. In our latest blog post, we dive into the pros and cons of these models and how they affect both Contract Research Organizations (CROs) and sponsors.
In our latest post, we explore:
What are Fully AI-Driven Trials? Explore the fully AI-driven trial model, where AI manages all aspects from recruitment to data collection, but faces compliance challenges under the EU AI Act.
Compliance and Data Transparency The EU AI Act's transparency rules pose issues for fully AI-driven trials, particularly in documenting complex AI systems.
Data Privacy and Security Learn about the Act's strict data governance requirements and how cross-border compliance adds complexity.
How Hybrid Trials Offer a Balanced Solution Hybrid trials blend AI with human oversight, ensuring safety, real-time decision-making, and regulatory compliance.
Personalized Oversight and Data Integrity in Hybrid Trials Human involvement improves ethical oversight, data integrity, and participant engagement, leading to more reliable outcomes.
Why This Matters The EU AI Act has made it essential for CROs to adapt their trial models to meet strict compliance requirements. Fully AI-driven trials may face delays and higher costs due to these regulations. In contrast, hybrid trials present a more flexible and compliant alternative, combining the strengths of AI with the necessary human oversight. This approach ensures trial quality, participant safety, and regulatory compliance, making hybrid trials an optimal choice for CROs and sponsors.
We invite you to read the full blog post below for a detailed exploration of how hybrid trials can help CROs navigate these regulatory challenges. Whether you’re a sponsor, CRO, or healthcare professional, this guide will provide valuable insights into the evolving landscape of clinical trials.
Feel free to connect with us if you have questions or need assistance with your clinical trial strategy!