Industry leaders gathered at the Summit for Clinical Ops Executives (SCOPE) 2024 in Orlando on February 12 to address the growing role of artificial intelligence in clinical trials, shifting the conversation from capability to responsibility.
Brian Martin, head of AI at AbbVie, set the tone for the discussion by emphasizing that technological feasibility is no longer the primary concern. "Technology is no longer the question. The questions that remain are the 'should we' questions; the questions of security, privacy, ethics, compliance," Martin stated, highlighting the current lack of comprehensive governance frameworks as regulators work to establish appropriate guidelines.
Current Applications and Challenges
AI's reach in clinical trials spans multiple domains, including drug development, patient recruitment, protocol creation, trial setup, and data processing. However, industry experts advocate for a measured approach in its implementation.
Hoifung Poon, General Manager at Microsoft Health Futures, proposed a nuanced perspective on AI integration. "I see AI as far from perfect, but I see a sweet spot using these services with a human to make them superhuman," Poon remarked. While acknowledging AI's potential to predict disease progression, he emphasized this remains a distant goal.
Data Quality and Bias Considerations
Samar Noor, head of statistical programming at Bristol Myers Squibb (BMS), raised crucial points about data bias in AI applications. While AI can help eliminate human bias in data processing, Noor pointed out that geographical disparities in clinical trial data present new challenges.
"We have to remember that AI will only be as good as the data sources that you feed so it is important that we consider bias," Noor explained. She noted that while BMS is expanding its data collection beyond U.S.-based trials to include European studies, significant gaps remain, particularly in Asian markets.
Regulatory and Ethical Framework
The discussion highlighted the urgent need for robust regulatory frameworks to govern AI use in clinical trials. As the technology continues to evolve, industry stakeholders must navigate complex privacy laws and compliance requirements while leveraging AI's capabilities.
The panel's consensus suggested that the future of AI in clinical trials lies not in replacing human expertise but in enhancing it through carefully considered implementation that prioritizes ethical considerations and data quality.
