Only about half of a select group of clinical trials could be well-emulated with available real world evidence, according to the newly discussed results of an FDA pilot program.
The FDA-funded program, known as RCT-DUPLICATE, helped researchers from the Brigham and Women’s Hospital in Boston try to evaluate whether randomized controlled trials can be duplicated with RWE across a range of therapeutic areas.
The initiative is part of the FDA’s work, mandated by Congress in the 21st Century Cures Act, on how it plans to evaluate the use of RWE to assess the effectiveness of medical products.
Read More: https://endpts.com/real-world-evidence-lessons-learned-from-an-fda-pilot-show-the-limits-of-emulating-rcts/