How Institutional Review Boards (IRBs) Support the Integrated Clinical Trial Model
The FDA’s draft guidance introduces an “integrated model” that embeds clinical trials into routine care settings to make research more accessible and patient centric. Conducting trials alongside regular healthcare is an approach that aims to streamline clinical research while reducing disruption for patients.
Key Takeaways and Considerations for the Integrated Model
This guidance outlines ideal use cases for the integrated model, which are primarily low-risk and postmarketing studies. The document also emphasizes the importance of quality design, informed consent, and patient safety. This is a powerful indication of the role of accredited IRBs in supporting ethical, compliant trials.
