One Day, Clinical Trials Will Represent The Real World

The FDA's Advancing Real-World Evidence (RWE) Program has made significant progress lately, leading to the agency's openness to innovative uses of RWE in clinical trial design. In fact, the FDA has recently approved a hybrid external control that combines synthetic control-arm patients with randomized patients in clinical trials, setting a precedent. While it's still early in using RWE to transform clinical trial design, many Life Sciences leaders are starting to take it seriously for regulatory submissions.

However, approvals based on RWE have primarily focused on off-label uses for drugs that were initially approved using conventional randomized controlled trial (RCT) designs. So, what needs to happen for RWE to reach its full regulatory potential? We discussed this with industry leaders during the One Day Summit, and here are some key takeaways.