AI and machine learning are reshaping drug development, offering new efficiencies across clinical trials while raising evolving regulatory expectations. Global regulators, including the FDA and EMA, are open to AI/ML but stress safety, transparency, and risk-based approaches to protect patients. Standards are emerging around explainability, bias mitigation, and lifecycle monitoring to ensure trustworthiness. Strategic applications span recruitment, participant stratification, and dose optimization, with potential to accelerate timelines and improve outcomes. Success depends on strong governance, cross-disciplinary expertise, and continuous collaboration with regulators.

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