The use of real-world evidence to support FDA post-approval study requirements for oncology drugs.

Published in: Expert review of anticancer therapy (2022)

As a greater proportion of safety and efficacy data generation for oncology drugs shifts to the post-marketing setting, RWE has the potential to become an integral component of PMR/PMC fulfillment.

Keyphrases

palliative care
electronic health record
machine learning
risk assessment
human health
artificial intelligence