Thursday, July 21, 2016

Real World Evidence, Bipartisan Policy, and the FDA

In June 2016, the Regulatory Focus newsletter at RAPS published an article, "New Report Calls on FDA to Clarify Use of Real World Evidence," (here).

The news article summarizes findings in a 32 page report issued by Washington's Bipartisan Policy Center.  The report discusses FDA evidence requirements from 1962 forward, and urges more pragmatic approaches to evidence evaluation.   Prestigious authors include Mark McClellan, Andrew von Eschenbach, and Patrick Soon-Shiong.   The report is online, here, and underscores themes we've heard over the past year or two in the 21st Century Cures effort.

For a 2016 academic article on a "certified data" approach to RWE, see here.
For a July 2016 FDA draft guidance on RWE in medical device decision-making, here.
For an August 2016 NEJM article on Pragmatic Trials, here.