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Advarra Establishes AI Council for Clinical Innovations

Advarra, a leader in regulatory review and clinical research technology, has made a groundbreaking move by launching the Council for Responsible Use of AI in Clinical Trials. This initiative brings together prominent leaders from the life sciences sector including Sanofi, Recursion, and Velocity Clinical Research, marking a significant step towards harnessing the power of artificial intelligence in clinical trials.

The primary objective of this council is to create standardized practices, reinforce governance, and establish measurable outcomes that can enhance the implementation of AI technology across various aspects of clinical trials. This collaboration leverages Advarra’s unique insights from its extensive experience in the clinical research ecosystem. With such respected organizations participating as founding members, the council aims to address the complex challenges faced by research sites and sponsors in real-time.

CEO of Advarra, Gadi Saarony, stated, "AI is shaping the future of clinical research, but its impact will only be substantial if we are responsible, collaborative, and transparent in its application." He emphasizes that the formation of this council will not only pave the way for innovative standards but will also ensure that AI contributes positively to the experiences of trial participants and the wider research community.

Laura Russell, senior vice president at Advarra, added, "The recent draft guidance from the FDA has sparked excitement within the life sciences field, recognizing AI’s transformative capabilities while also underlining the urgent need for clarity in its deployment and the regulatory landscape. Our role through this council is to tackle these challenges head-on, setting a bold vision for AI’s responsible use to ultimately enhance patient outcomes."

The council will focus on a few specific goals:

• - Developing a unified vision on how AI can revolutionize clinical trials.
• - Formulating standards, guidelines, and frameworks for ethically and effectively deploying AI.
• - Establishing key performance indicators (KPIs) to assess both immediate efficiencies and the long-term impacts of AI in clinical development timelines.

Michel Rider, the global head of digital RD at Sanofi, remarked, “As AI becomes more integrated into clinical development, it’s crucial for the industry to unify around real-world best practices instead of just theoretical models. This council is an unprecedented opportunity to shape viable, scalable AI governance and implementation strategies.”

Additionally, Sid Jain, Senior Vice President at Recursion, highlighted the council’s unique focus on operational and real-world data applications. He noted, “We’re enthused about leveraging AI to enhance speed and accuracy within clinical trials. Our collaboration here aims for real-world applications that can expedite the availability of effective treatments to patients.”

The Council for Responsible Use of AI in Clinical Trials is aiming to produce actionable insights, which will be shared through white papers, peer-reviewed articles, and public presentations. Furthermore, the council intends to host public webinars and cross-industry discussions to promote transparency and nurture collective knowledge.

In engaging with various regulatory authorities and industry organizations, the council will seek feedback that ensures their strategies remain relevant and effective. This proactive engagement serves to underline their commitment to a forward-thinking approach that benefits the entire clinical research ecosystem.

To discover more about this initiative or to explore participation, one can visit Advarra Council for Responsible Use of AI.

About Advarra

Advarra is redefining the traditional barriers in clinical research by fostering a collaborative environment among patients, research sites, sponsors, and CROs, with the goal of accelerating clinical trials. As the number one provider in research review services and a leader in site/sponsor technology, Advarra is trusted across the globe by leading biopharma companies and clinical investigators. Their innovative solutions prioritize collaboration, transparency, and speed to refine trial operations and improve patient safety and engagement.