Advarra Launches AI Council to Advance Responsible Innovation in Clinical Trials
Thursday, June 19, 2025
Advarra has announced the formation of the Council for Responsible Use of AI in Clinical Trials.
This initiative aims to foster collaboration within the life sciences sector, focusing on the responsible integration of artificial intelligence (AI) into clinical trial operations.
The newly established Council includes representatives from key life sciences organisations such as Sanofi, Recursion, and Velocity Clinical Research. These founding members bring a wide range of expertise in AI and machine learning, regulatory science, data strategy, and clinical development. The Council will act as a platform for sharing insights, setting standards, and addressing critical challenges surrounding the application of AI in clinical research.
Advarra’s role as a central player in the clinical research ecosystem, with its comprehensive understanding of study processes and stakeholder challenges, places it in a unique position to guide this industry-wide effort.
The Council is focused on accelerating the responsible use of AI across all stages of the clinical trial lifecycle. Key areas of work will include:
- Creating a shared understanding of AI’s role in transforming clinical research.
- Developing standards and ethical frameworks for the safe and effective use of AI tools.
- Defining measurable outcomes to track both immediate improvements and long-term impact.
- Promoting data security, system interoperability, and practical solutions for operational needs.
This approach is designed to align with the latest regulatory considerations, including recent draft guidance from the US FDA, which highlights the need for clarity and accountability in AI applications.
As the use of AI becomes more common in clinical development, there is growing interest in using real-world and operational data to improve trial efficiency and accuracy. The Council aims to translate theoretical advancements into real-world best practices by focusing on protocol amendments, participant recruitment, data handling, and decision-making processes.
This initiative recognises that progress in AI must go hand-in-hand with clear governance, shared responsibility, and stakeholder alignment to truly benefit trial participants, sponsors, sites, and the wider research community.
To support its goals, the Council will share its work through white papers, peer-reviewed publications, webinars, and conference presentations. It also plans to host industry roundtables and engage with regulatory bodies and standards organisations to gather feedback and ensure its recommendations are broadly relevant and forward-looking.
Through this collaborative model, the Council aims to guide the responsible use of AI in clinical trials and contribute to improving outcomes across the healthcare and life sciences landscape.
Source: prnewswire.com
