Real-world evidence (RWE) and artificial intelligence (AI) have the potential to accelerate drug development via multiple mechanisms, providing valuable insights into drug safety and efficacy in the real-world setting. For instance, RWE may better identify patients most likely to benefit from a drug, enabling more efficient and targeted recruitment for clinical trials. Also, RWE is useful in monitoring drug safety and efficacy after approval, enabling earlier detection of adverse events and insight into broader indications. RWE can help identify patient subgroups most likely to respond to a particular treatment in diseases such as cancer, where targeted therapies are becoming the norm. Finally, RWE addresses gaps in knowledge of drug activity in populations historically under-represented in randomized clinical trials. However, important concerns remain to be addressed, including patient privacy, data quality, and regulatory acceptance of RWE.