Tuesday, February 7, 2017

Brief Blog: 21st Century Cures and the CMTP Focus on Real-World Evidence

Real world evidence has been extensively discussed in recent years, two Washington highpoints being a June 2016 white paper on RWE by the Bipartisan Policy Center (here) and 21st Century Cures, Section 3022, encouraging the FDA to look deeper into RWE in approval decisions (here, here).

(The FDA weighed in on its view of RWE in the New England Journal, December 8, 2016, here.)

The Green Park Collaborative, organized by the Baltimore-based Center for Medical Technology Policy (CMTP), has set up a resource webpage with multiple detailed documents to help parties assess and validate the quality of Real World Evidence.

Website here.  39-page white paper on the RWE Decoder project, here.

For a video on the evidence framework goals of CMTP, see an interview with its leader Dr. Sean Tunis, here.

For a February 21, 2017 editorial in JAMA on observational evidence, see here.  For a July 2016 FDA guidance on RWE, here.