How Digital Medicine Platforms Can Enable Next Generation Patient Powered Registries and Real World Evidence

Yesterday the American Gastroenterology Association provided updates of the NIH-Funded National Registry for Fecal Microbiota Transplantation (FMT) that will be utilizing a leading digital medicine platform to engage 4000 patients from 65 sites throughout North America

FMT is a procedure in which fecal matter, or stool, is collected from a tested donor, mixed with a saline or other solution, strained, and placed in a patient, by colonoscopy, endoscopy, sigmoidoscopy, or enema. The purpose of fecal transplant is to replace good bacteria that has been killed or suppressed, usually by the use of antibiotics, causing bad bacteria, specifically C. difficile, or C. diff., to over-populate the colon. C. Diff has been responsible for almost half a million infections and about 30,000 deaths annually in US alone.

The Registry is first-of-its-kind patient powered national registry run by a provider association to answer many scientific questions. It has 3 unique characteristics. 

1.    The Registry is unifying efforts occurring in parallel, within FMT and microbiota research at 65 disparate centers throughout the Continent. There are about 700 microbiome studies reported in ClinicalTrials.gov today, many of them being single site studies.

2.    It is first time that patients with FMT will be followed over a 10-year period, ensuring adequate time and resources to more fully grasp both the short- and long- term potential benefits and side effects of FMT. This will include metabolic, neurological, and behavioral side effects, creating an unprecedented amount of outcome and stool biobank data in the area.  

3.    The third differentiator, which is perhaps the most unique, is that the registry is able to scale the efforts nationally and enable 10-year follow-up with limited resources. This is because data collection from years 2-10 is not through research coordinators but directly by patients. Automated patient engagement throughout a patient’s FMT journey, including data collection that occurs well after a patient’s initial visit with their gastroenterologist, is happening through digital medicine platform, powered by Rx.Health.

The FMT registry is a great model of Next Gen Registries that have started to use patent centered ePROs as mainstay for outcomes research and real-world evidence for drugs and devices. Not surprisingly, the same platforms that are leading digital transformation for  value-based care delivery are now  enabling transformation of clinical research, which seems to be the new Frontier!!