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# Integrating RCTs into Routine Clinical Practice
- URL: https://www.fdaweb.com/integrating-rcts-into-routine-clinical-practice/
- Published: 2024-09-17T12:00:00.000Z
- Updated: 2026-09-14T14:41:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157793

FDA has published a guidance, *Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice*, that is intended to support the conduct of randomized clinical trials (RCTs) with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice. The [document](https://www.fda.gov/media/181871/download?ref=fdaweb.com) says that leveraging established healthcare institutions and existing clinical expertise in the medical community can reduce startup times and speed trial enrollment.

The guidance applies to studies involving FDA-approved drugs being studied for new indications, populations, routes of administration, or doses; drug safety studies for FDA-approved drugs; other postmarketing studies for FDA-approved drugs; comparative effectiveness studies for FDA-approved drugs; and trials of unapproved drugs when the safety profile is sufficiently characterized and the drug is appropriate to be administered and managed in the setting of routine clinical practice. The guidance does not address non-interventional studies.

FDA says sponsors are encouraged to employ a quality-by-design approach to achieve the scientific objective and ensure adherence to FDA requirements, including those relating to good clinical practice. “Regulatory requirements for trials integrated into routine clinical practice are the same as those for traditional clinical trials,” it says.