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Crohn’s & Colitis Foundation picked for FDA MyStudies project
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The FDA has selected the Crohn’s & Colitis Foundation as one of just two patient organizations that will take part in its Real-World Evidence Program using the MyStudies App, which will allow the foundation to expand research and data systems, according to a press release.
The FDA’s MyStudies app is an open source mobile device and data storage system that was developed to make it easier for patients to input their data in support of clinical trials and other studies. The Crohn’s & Colitis Foundation will use this opportunity to expand its IBD Plexus platform and launch a digital inflammatory bowel disease tracker called IBD PROdigy.
“IBD PROdigy will become a key link between patients’ experiences and scientific advancements in IBD, enabling deeper patient participation in research. We cannot gather real-world data efficiently and effectively from patients without engaging with user-friendly tools such as IBD PROdigy,” Angela Dobes, senior director of the IBD Plexus program, said in the release. “The more the app improves our interaction with patients, the more valuable and enriched data we will get. This app will engage patients and enable us to follow and learn from them throughout their disease journey.”
With the launch of IBD PROdigy in 2020, the foundation will be able to link patient-reported outcomes to clinical data, bio samples and their derived molecular data. The program will first see action in the SPARC IBD cohort — a longitudinal study aimed at exploring predictors that connect each individual patient to the right therapy — before being released in other IBD Plexus cohorts.
The foundation hopes the program will help reduce the time and cost needed to get a study started and let researchers dive deeper into hard-to-study sub-populations. Data collected through the app could also help clinicians create new interventions and improve patient health, according to the release.
“IBD PROdigy will provide IBD Plexus cohorts the opportunity to fill in important information gaps critical to advance research,” Dobes said in the release. “Periodic data collection that happens within the clinical delivery system only offers a snapshot into a patient’s disease. The app will allow us to fill in known missing care events, such as ER visits, and also incorporate patient’s symptoms and experiences. Linkage of this patient-reported data to clinical and molecular data then acts as a catalyst to augment research. These robust, multi-dimensional datasets will lead to stronger evidence to support and help expedite regulatory decisions.”
For more information: www.crohnscolitisfoundation.org