FDA Expanding Real-World Evidence Demonstration Project
FDA is expanding its RCT DUPLICATE demonstration project with Aetion and Brigham and Women’s Hospital to use real-world evidence (RWE) to predict the results of seven ongoing Phase 4 trials. An Aetion statement says it is the first time that researchers will estimate the results of randomized controlled trials that have not yet concluded. Aetion says the project will inform FDA’s standards for using RWE in regulatory decision-making by identifying when and where RWE based on healthcare databases can provide robust estimates of treatment safety and efficacy for sNDAs.
The demonstration project is said to be a critical part of FDA’s Real-World Evidence Program that was mandated by the 21st Century Cures Act. Aetion says it is training agency staff on its platform to enable them to work with its technology to review a completed RWE study and test its robustness. RCT DUPLICATE anticipates interim results in mid-2019 and full results at the end of 2020.