Regulatory Agencies Act to Bridge the Evidentiary Gap: Might This Lead to an Expanded Role for Pragmatic Trials?
Abstract
On the eve of FDA’s release of its Real-World Evidence Program Framework,
ISPOR examines steps that regulatory agencies are taking to bridge the evidentiary gap
and asks what role pragmatic clinical trials may play in regulatory decision making.
ISPOR examines steps that regulatory agencies are taking to bridge the evidentiary gap
and asks what role pragmatic clinical trials may play in regulatory decision making.