By David Thompson, PhD, Senior Vice President, Real World Evidence Late Phase at Syneos Health
Anyone and everyone involved in drug development and commercialization is waiting with bated breath as the FDA prepares to develop and implement a program evaluating the potential use of Real World Evidence (RWE) for regulatory decisions. We’ve known for certain this is coming at least since passage of the 21st Century Cures Act in 2016. But the forces leading to this moment have been at work for years – decades, really. Now that we’re in the home stretch, the sense of urgency is palpable as the industry anticipates what the FDA will recommend and envisions its own path forward.