In the research article “Exploring the feasibility of using real-world data from a large clinical data research network to simulate clinical trials of Alzheimer’s disease,” the authors explored the feasibility of using real-world data (RWD) for clinical trial simulation.
Clinical trials are a vital part of new pharmaceutical drug development and discovery, assessing the efficacy and safety of new drugs, as well as possible reactions in patients.
“While the rigorously controlled conditions of clinical trials can reduce bias and improve the internal validity of the study results, they also come with the drawbacks of high financial costs and long execution time,” the study explains.
Currently, no effective drugs have been developed for the treatment and prevention of Alzheimer's disease, despite large investments in preclinical studies.
The authors propose the simulation of clinical trials, which would not only benefit pharmaceutical companies, but most importantly, patients. “Clinical trial simulation (CTS) is valuable to assess the feasibility, investigate the assumptions, and optimize the study design before conducting the actual trials”.
The research obtained a massive base of information thanks to data from the OneFlorida Clinical Research Consortium, a clinical data research network funded by the Patient-Centered Outcomes Research Institute (PCORI).
The research presented the simulation of a clinical trial “considering three different simulation scenarios. In the one-arm simulation scenario, we attempted to simulate an external control arm for the original trial.”
Check the full study at the following link: https://www.nature.com/articles/s41746-021-00452-1
