FDA Expands Real-World Evidence Partnership with Brigham and Women’s
The FDA, Brigham and Women’s Hospital, and Aetion are expanding their real-world evidence (RWE) demonstration to predict the results of seven ongoing FDA drug trials. The FDA drug or treatment trials are in Phase IV, meaning the drug or treatment is being tracked over a long period for a greater number of patients. The partnership between the three organizations, called RCT DUPLICATE, marks the first time researchers will estimate the results of randomized controlled trials that haven’t yet finished. The expanded partnership will build on the original...