The integration of artificial intelligence and digital technologies in clinical trials is prompting industry leaders to seek a delicate balance between innovation and ethical safeguards, as discussed at the recent Outsourcing in Clinical Trials (OCT) DACH 2024 conference in Zurich, Switzerland.
Regulatory Bodies Respond to AI Integration
The US Food and Drug Administration (FDA) has taken proactive steps to address the growing role of AI in clinical research. Eva Herrmann-Keiner, senior clinical operations manager at Neurimmune, noted that regulatory bodies are increasingly aware of the need for guidance in this space. The FDA has established dedicated working groups and released discussion papers focusing on AI/machine learning applications in drug development and manufacturing.
Dr. Khair ElZarrad, director of the Office of Medical Policy within FDA's Center for Drug Evaluation and Research, revealed that the agency has formed an internal steering committee to evaluate digital health technologies (DHTs) and decentralized trials (DCTs). However, industry professionals indicate that more detailed guidelines are still needed for proper implementation.
Ethical Considerations and Patient Access
Francine Metelo Masega-A-Gulema, regional lead of WEIC DEICE at Pfizer, emphasized that technological advancement must align with ethical principles. A key concern is ensuring equitable access to AI-powered clinical trials across different populations and regions.
"Maybe we can ask ourselves, are they accessible?... The people don't have the same possibilities because we don't all have the same access," Metelo noted, highlighting the importance of adequate infrastructure to support participation.
Building Trust with Underrepresented Communities
The implementation of new technologies must address historical barriers faced by underrepresented communities in healthcare access. Industry leaders stress the importance of designing inclusive trials that can help build trust with these populations while leveraging technological innovations.
Risk-Based Approach to AI Implementation
Experts advocate for a tiered approach to AI integration in clinical trials. Herrmann-Keiner emphasized that while there may be more flexibility in using AI for operational tasks, stricter oversight is necessary when technology directly impacts patient care. "We cannot simply be creative wherever we want," she cautioned, highlighting the need for clear boundaries as technology moves closer to patient interaction.
Future Outlook
As the industry awaits more comprehensive regulatory guidance, the focus remains on ensuring that technological advancements serve all stakeholders equitably. The goal, as summarized by Metelo, is to "uplift" clinical trial processes while ensuring that the mission is accomplished in an equitable manner, recognizing that "accessibility and equity are not the same."
