In this episode, Darshan explores how artificial intelligence (AI) is transforming clinical trial design, with a focus on using real-world data (RWD). The episode dives into the FDA’s recognition of AI’s potential to enhance clinical trials by using data from electronic health records (EHRs), medical claims, and disease registries. AI’s ability to analyze large data sets enables identification of patterns that can predict chronic disease progression, leading to more personalized and effective treatments.

Key benefits discussed include AI's role in continuous monitoring of trial subjects, real-time data analysis, and ensuring data accuracy through cleaning and curation, such as identifying duplicate entries and filling data gaps. AI's capacity to identify EHR phenotypes and group patients based on relevant characteristics allows for targeted and efficient trials, paving the way for precision medicine.

Despite its advantages, the “black-box” problem of AI, where decision-making processes aren’t fully transparent, remains a challenge. However, with regulatory oversight and consistent monitoring, AI is poised to revolutionize clinical trials, making them more efficient and inclusive. 

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