The Food and Drug Administration’s (FDA) Sentinel program was launched in 2008 and has been a considerable investment for the FDA, as indicated by Janet Woodcock in a recent Applied Clinical Trials news article. The Sentinel system is an important part of routine safety surveillance for pharmaceuticals and other medical products. The FDA plans to expand use of the Sentinel system to public health and quality improvement activities as well as effectiveness research in its “Guardian” system.

CTTI supported FDA efforts to explore the potential for using the Sentinel database beyond safety surveillance previously; CTTI and FDA’s Mini-Sentinel jointly published a report describing the capability and willingness of Mini-Sentinel’s Data Partners to collaborate in a variety of types of randomized trials, using the Mini-Sentinel (now Sentinel) Distributed Dataset. CTTI and Sentinel are now collaborating to design and implement a trial based on findings in the report. As mentioned in the recent Applied Clinical Trials news article, CTTI will facilitate the development and execution of a protocol for a randomized trial (IMPACT-AF) to study an educational intervention to improve the appropriate use of anti-coagulation for atrial fibrillation. This trial is a proof of concept study intended to determine whether it is possible to conduct a trial within the “Guardian” system. CTTI is proud to support the FDA’s efforts to expand their safety monitoring system to become a national resource with broader applications, specifically in more real-world clinical studies.