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.

patient standing at desk talking to medical staff at doctor's office
Draft FDA guidance outlines when sponsors can integrate local healthcare providers into clinical trials. • Source: Shutterstock

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