FDA To Hold Workshop on Generating Real-World Evidence

The FDA has scheduled a July 11 public workshop on using randomized clinical trials to generate real-world evidence for use in regulatory decisions.

The workshop will consider the framework for the RWE program the agency issued in December 2018, including sources of RWE, gaps in data collection activities, standards and methodologies.

Likely discussion topics will include study design elements and study populations, potential difficulties presented by blinding, randomization and bias, and capturing outcomes in clinical care settings.

The workshop will be held at the Westin City Center in Washington, D.C.