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

 
• By Sarah Karlin-Smith

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trials into routine clinical practice may be fairly limited, according to a new US Food and Drug Administration draft guidance.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

  • Trials most appropriate for integration into clinical practice are those with streamlined protocols and procedures that focus on essential data collection including trials that are sometimes referred to as point of care trials, or large simple trials

The 17 September draft emphasizes that this trial design approach will typically only work for already approved drugs being studied for new

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