BD is collaborating with Mayo Clinic Platform to access de-identified patient data from Mayo Clinic Platform_Discover to perform post-market surveillance on its products for innovation and to unlock a more efficient path to market, with the ultimate goal of improving patient care.
Mayo Clinic Platform_Discover, an enabling product of Mayo Clinic Platform, represents one of the most robust de-identified data sets available from 10 million patients, including both structured and unstructured data, images, 1.2 billion lab test results, 3 million echocardiograms and more than 640 million clinical notes. Using data mining, artificial intelligence (AI) and machine learning tools, BD will analyze the real-world data — which provides information outside what is typically gathered in a clinical trial — to generate deeper insight into the patient experience that will help the company accelerate and enhance innovation around both existing products and unmet needs.
"For years, randomized control trials have been considered the gold-standard in evaluating safety and efficacy for medical devices, but experts from industry and academia who are examining the tight parameters around clinical trials are seeing added value in leveraging insights from real-world data to truly understand whether we are meeting patients' needs," said Lisa Boyle, vice president of global clinical affairs and medical affairs strategy for BD. "We need to be leveraging real-world evidence, using datasets like those from Mayo Clinic Platform, to understand the many parameters that we wouldn't normally capture in a clinical trial and understand patients' care pathways and address the needs of diverse patients in order to establish better solutions for better outcomes and experiences."
By using the historical data for predictive modeling, BD also will look to make more accurate forecasts related to device use, to increase efficiency for new clinical trials and to generate evidence. BD will also apply the Mayo Clinic data to support new claims for its products and streamline medical device regulatory submissions.
"Our next generation analytical tools and curated de-identified patient data create a dynamic, privacy-protected environment for discovery that few in the industry can provide," said Steven Bethke, vice president for product portfolio, Mayo Clinic Platform. "Mayo Clinic Platform_Discover enables medical technology leaders such as BD to derive key insights as they develop solutions for their customers and patients as quickly and safely as possible."