Forbes September 18, 2023
The use of Artificial Intelligence (AI) and Machine Learning (ML) in clinical research is rapidly evolving, offering a glimpse into a future where medical innovation is driven by data-driven algorithms. Recent developments, regulatory considerations, and the promising future of AI in clinical research are reshaping the landscape of drug development and patient care.
Regulatory Status and Oversight
The U.S. Food and Drug Administration (FDA) has recognized the transformative potential of AI in healthcare. In May 2023, the FDA published a discussion paper outlining the current and future applications of AI/ML in drug development. This paper addressed core issues like human-led governance, data quality, and model development standards. It emphasized a risk-based approach tailored to specific contexts of AI/ML use, underlining...
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