FDA, Brigham and Women's Hospital RWE project seeks to predict Phase IV trials

The Food and Drug Administration and Brigham and Women’s Hospital are diving deeper into a program announced last year to incorporate real-world evidence into regulatory decision making as part of a partnership with a large academic institution.

New York-based software company Aetion said Wednesday that the FDA would expand its partnership with the Boston hospital to use RWE to recreate randomized, controlled clinical trials, also known as RCT DUPLICATE. The expansion will involve attempting to use RWE to predict the results of seven ongoing Phase IV trials and, according to Aetion, marks the first time researchers will attempt to estimate the results of randomized controlled trials that have not yet concluded.

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The original scope of RCT DUPLICATE was to attempt to replicate results from 30 randomized controlled trials that had already been completed and whose results had been published. Of those studies, 23 resulted in FDA approvals, while seven resulted in rejections. The trials came from four disease areas, namely cardiovascular disease, endocrinology, musculoskeletal and pulmonary.

“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,” Harvard Medical School assistant professor of medicine and RCT DUPLICATE program lead Jessica Franklin said in a statement. “This additional work will be vital as we develop a process model for the implementation of regulatory-grade RWE studies.”

The FDA is actively looking for ways to incorporate RWE into regulatory decision making, as mandated by the 21^st Century Cures Act. However, such efforts are not without their critics, with many experts regarding randomized controlled trials as the gold standard of evidence.

Data published earlier this week in the Journal of the American Medical Association from a study conducted by Flatiron Health and Foundation Medicine was shown to be consistent with data from clinical trials of patients with non-small cell lung cancer treated with PD-1 and PD-L1 inhibitors.