Harnessing the Power of Real‐World Evidence (RWE): A Checklist to Ensure Regulatory‐Grade Data Quality

Abstract

The role of real-world evidence (RWE) in regulatory, drug development, and healthcare decision-making is rapidly expanding. Recent advances have increased the complexity of cancer care and widened the gap between randomized clinical trial (RCT) results and the evidence needed for real-world clinical decisions. Instead of remaining invisible, data from the >95% of cancer patients treated outside of clinical trials can help fill this void.