Using Machine Learning to Identify a Suitable Patient Population for Anakinra for the Treatment of COVID-19 Under the Emergency Use Authorization

https://www.fda.gov/drugs/spotlight-cder-science/using-machine-learning-identify-suitable-patient-population-anakinra-treatment-covid-19-under?utm_medium=email&utm_source=govdelivery FDA recognizes the increased use of artificial intelligence and machine learning (AI/ML) throughout the drug development life cycle and its potential to accelerate this process. For example, AI/ML approaches can be applied to clinical trial patient selection strategies during drug development to predict a patient’s clinical outcome after receiving the investigational treatment based on baseline characteristics (e.g., demographic information, clinical data, vital signs, labs, medical imaging data, and genomic data). These predictive models can identify patients more likely to have worse prognoses or patients more likely to benefit from a treatment, ultimately helping to demonstrate the effectiveness of a drug.