Simulating Colorectal Cancer Trials Using Real-World Data.

ABSTRACT:

Purpose

Using real-world data (RWD)-based trial simulation approach, we aim to simulate colorectal cancer (CRC) trials and examine both effectiveness and safety end points in different simulation scenarios.

Methods

We identified five phase III trials comparing new treatment regimens with an US Food and Drug Administration-approved first-line treatment in patients with metastatic CRC (ie, fluorouracil, leucovorin, and irinotecan) as the standard-of-care (SOC) control arm. Using Electronic Health Record-derived data from the OneFlorida network, we defined the study populations and outcome measures using the protocols from the original trials. Our design scenarios were (1) simulation of the SOC fluorouracil, leucovorin, and irinotecan arm and (2) comparative effectiveness resea

SUBMITTER: Chen Z 

PROVIDER: S-EPMC9848597 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature