CRO sector must use AI responsibly, says new Advarra-backed council

Artificial intelligence (AI) could transform the trials sector, but the technology needs to be used responsibly, according to a new advocacy group established by Advarra.

The company announced it founded the Council for Responsible Use of AI in Clinical Trials in collaboration with founding members Sanofi, Recursion, and Velocity Clinical Research last month. The aim is to develop methods of governing AI models and define measurable outcomes to advance the use of the technology in trials.

Laura Russell, senior vice president, head of data and AI product development at Advarra, told Clinical Insider, “The responsible use of artificial intelligence in clinical trials hinges on a principled approach that ensures technologies enhance, not compromise, ethical standards, scientific integrity, and stakeholder trust.

“Advarra’s Council for the Responsible Use of AI in Clinical Trials defines responsible use through a multi-stakeholder lens. The focus is on operational realism, human oversight, and measurable outcomes, rather than technical perfection or compliance with checkboxes. This approach ensures that AI supports the complex, high-stakes environment of clinical research in a way that is both practical and principled,” she said.

The council will publish findings and recommendations in peer-reviewed journals and at industry conferences. It also plans to lead webinars and host roundtables to promote transparency, knowledge-sharing, and collaboration.

Russell told us, “The council plans to publish working group outputs beginning in late 2025. Initial frameworks and guidance will be released in early 2026. These materials will reflect iterative feedback from stakeholders, with updates and refinements made as needed.

“The council’s strategy is to develop clear, actionable guidance and then invite broad feedback from across the research ecosystem, including sponsors, sites, regulators, and technology partners. We recognize that adoption takes time, so our approach is iterative. We’ll refine the recommendations based on real-world use, evolving standards, and stakeholder input.”

She added that, to ensure broad access, Advarra will host a dedicated webpage where the entire community can easily access the council’s materials, updates, and insights.

Advarra cited recent US FDA draft guidelines on the use of AI as a motivation for the development of the council, explaining the industry needs greater clarity on real-world implementation and regulatory expectations.

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