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

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trials into routine clinical practice may be fairly limited, according to a new US Food and Drug Administration draft guidance.

Key Takeaways

Integrating clinical trials into routine practice could make participation easier for patients, improve diversity of enrollment and thus make study results more generalizable, FDA...

The 17 September draft emphasizes that this trial design approach will typically only work for already approved drugs being studied for new indications, routes of administration, or doses.

Integrating Trials Into Clinical Practice: US FDA Guidance Outlines Limited Use Cases

Key Takeaways

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