Becton Dickinson and Company is teaming up with Mayo Clinic to improve post-market device surveillance. The collaboration calls for the Franklin Lakes, NJ-based company to access de-identified patient data from Mayo Clinic Platform_Discover.
Mayo Clinic Platform_Discover is a part of the Mayo Clinic Platform and has de-identified data sets available from 10 million patients. These data sets include 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, next generation 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.
BD said it will also use the historical data to make 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.
"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."