Premier Weighs in with FDA on Using Artificial Intelligence and Machine Learning in Drug Development

Premier submitted comments to the Food and Drug Administration (FDA) regarding its discussion paper on using artificial intelligence (AI) and Machine Learning (ML) in the development of drug and biological products.

Premier supports the development of the FDA's discussion paper as a positive step towards recognizing the ways in which technology can be leveraged to reduce costs, improve data quality and access, expedite processes and advance health equity. Specifically, Premier applauds the FDA’s efforts to incorporate emerging technologies into drug development and provide clarity for clinical trial innovators. In its comments, Premier recommends that the FDA consider:

• Issuing clear guidance on patient consent and data-sharing requirements in clinical trials, particularly with the rise of promising technology applications for real-world data in decentralized clinical trials and synthetic control arms;
• Clarifying applicability of anti-kickback statute in certain situations that may arise in innovative trial designs and recruitment processes;
• Clearly specifying a minimum cybersecurity standard for the transmission and storage of participant health data using digital health technology;
• Incentivizing continued innovation by protecting intellectual property while holding developers to high standards of accountability for reliable, valid and unbiased outcomes; and
• Taking steps to capture, monitor and manage pre-specification activities in drug development.