Opportunities for drug sponsors to integrate randomized controlled clinical trials into routine clinical practice may be fairly limited, according to a new US Food and Drug Administration draft guidance.
Integrating Trials Into Clinical Practice: US FDA Guidance Outlines Limited Use Cases
While they could speed enrollment and lead to more representative samples, based on what FDA says local health care providers would be allowed to do as part of trial conduct, there may only be limited opportunities to integrate clinical studies into routine clinical practice.
