THE 5^th STAT4ONC ANNUAL SYMPOSIUM

SHORT COURSE 1

May 4, 2022
8:00 AM – 12 :00 PM CT

Use of Real-World Evidence in Precision Oncology Drug Development

Jie Chen, Elixir Clinical Research & Overland Pharmaceuticals

Real-world data (RWD) and real-world evidence (RWE) have traditionally been used in medical product development. Since the passage of the 21st Century Cures Act in 2016, the use of RWD and RWE in product development and regulatory decision-making has received increasing attention. Recently, the US Food and Drug Administration issued several guidance documents on the use of RWD and RWE to support regulatory decision-making for drugs and biologics, paving the ways for the use RWD and RWE in drug development and regulatory submission. This short course will provide an overview on the use of RWD and RWE in the development of precision oncology drugs. Specifically, this short course will present (1) a review on the use of RWD and RWE in clinical trials of oncology drug development, (2) phenotyping of patients based on their clinical characteristics to identify patients who would benefit from a specific therapy, (3) clinical prognostic models to estimate prognosis of individual patients, (4) treatment toxicity assessment based on RWD, and (5) dynamic treatment regimens to optimize individual patient treatments based on their evolving characteristics. Illustrative examples are given throughout the short course.