A new industry council aims to shape best practices for applying artificial intelligence (AI) responsibly in clinical research, as momentum builds across the life sciences sector for smarter and faster clinical trials.

Advarra, in collaboration with leaders from Sanofi, Recursion, and Velocity Clinical Research, has announced the formation of the Council for Responsible Use of AI in Clinical Trials. The council will focus on developing shared standards and frameworks to guide the safe and effective application of AI across study design, operational processes, and data workflows.

AI tools are increasingly being used in areas such as protocol optimization, patient recruitment, and site selection, but concerns remain around implementation, regulatory clarity, and reproducibility. The council’s remit includes defining performance benchmarks, model governance frameworks, and data interoperability goals.

“AI’s value in research will depend on how it is applied,” said Michel Rider, global head of digital R&D at Sanofi. “Industry collaboration is essential to turn early promise into meaningful outcomes for patients.”

The initiative follows recent draft guidance from the FDA that calls for greater transparency and oversight in the use of AI tools in drug development. Council members say the goal is to balance innovation with practical guardrails that reflect both technical capabilities and ethical considerations.

Laura Russell, senior vice president and head of data and AI product development at Advarra, said the work would “support efforts to align regulatory expectations with operational needs and define measurable value from AI deployments.”

The council intends to release recommendations through white papers, academic publications, and public forums, and will collaborate with standards bodies and regulators to ensure alignment across the research ecosystem.