Translational Medical Research Commons^™

Using Adaptive Research Design To Define The Proper Methodology To Use A Data Peek For Power: Step By Step Process, Tom Wasser

Advances in Clinical Medical Research and Healthcare Delivery

When planning or conducting research in the hospital setting, often termed Real-World Environment (RWE), therapeutic assumptions and outcomes are often different than in the Randomized Clinical Trial (RCT) where medications, devices and therapies are tested and developed. This is because RWE research has a lack of experimental control, additional confounding due to patient complications and comorbid conditions, lack of pure patient selection and compliance with therapy in the patients being treated and many other factors as well. However, when RWE experiments are conducted, sample size determination using data from the RCT is common because that is the only data that …