Exploring the feasibility of using real-world data from a large clinical data research network to simulate clinical trials of Alzheimer's disease.

ABSTRACT: In this study, we explored the feasibility of using real-world data (RWD) from a large clinical research network to simulate real-world clinical trials of Alzheimer's disease (AD). The target trial (i.e., NCT00478205) is a Phase III double-blind, parallel-group trial that compared the 23 mg donepezil sustained release with the 10 mg donepezil immediate release formulation in patients with moderate to severe AD. We followed the target trial's study protocol to identify the study population, treatment regimen assignments and outcome assessments, and to set up a number of different simulation scenarios and parameters. We considered two main scenarios: (1) a one-arm simulation: simulating a standard-of-care (SOC) arm that can serve as an external control arm; and (2) a two-arm simulation: simu

SUBMITTER: Chen Z 

PROVIDER: S-EPMC8121837 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature