In a recent development, the US Food and Drugs Administration (FDA) has expanded its RWE capabilities by partnering with health care technology company, Aetion and Brigham and Women’s Hospital to predict the results of seven ongoing Phase IV randomised controlled trials (RCTs).
Known as the “RCT Duplicate Program”, this will be the first time researchers will use RWE to predict the outcomes of RCTs before completion.
The RCT Program is part of the FDA’s Real-World Evidence Program, mandated by the 21st Century Cures Act, which came into effect on 13 December 2016 with the aim of helping to:
“accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.”
Biostatistician at Brigham and Women’s Hospital and RCT Duplicate Program Lead, Jessica Franklin says:
“predicting the results of clinical trials before they’re completed is important for showing that in certain circumstances real-world evidence could potentially substitute for a trial.”
MAP BioPharma will be monitoring closely, and report further developments via MAP News.