FDA’s Center for Devices and Radiological Health (CDRH) plans to embrace the use of big data and patient reported outcomes in regulatory decision making, according to its 2016 Regulatory Scientific Priorities.
The U.S. regulatory paradigm is out of sync with our innovation cycles and data channels, said Jeffrey E. Shuren, M.D., CDRH Director, in previewing the priorities at AdvaMed 2015 in October. A medical device ecosystem based on data, including crowd sourced clinical data, a national evaluation system, unique device identification and patient reported outcomes and preferences—if these could all coexist with supportive reimbursement models, Shuren said, it would be a game-changer to reduce the time and cost involved in getting products to market.
Shuren’s premise is that the multitudes of data streams within healthcare should be leveraged to support the ability to set information standards, develop benefit/risk profiles and establish quality checks to determine what data needs to be collected on a device before it is approved.
“Rather than thinking about premarket and postmarket, it’s patient access,” Shuren says. “The more we understand about the technology, the more we broaden patient access. This has implications not only on the regulatory side, but adopted on the reimbursement side; you think [differently] about funding clinical studies, because really a clinical study is about patient access to a technology. If you think about it that way, it changes the paradigm.”
FDA’s announcement comes months after major companies announced that they seek to harvest and analyze larger and broader sets of data to impact patient outcomes beyond device manufacturing. In April, Medtronic and Johnson & Johnson announced big data partnerships with IBM. Medtronic’s work will focus on its diabetes business, while Johnson & Johnson and IBM are developing coaching systems centered on pre- and postoperative patient care for joint replacement and spinal surgery.
The general topic of big data has brought up warranted concerns over the years. One pertains to security concerns over privacy protection. Another relates to the ways that data is pulled and sorted. If data is collected for different purposes and in different ways and then merged, it is difficult to draw meaningful conclusions. A third concern is the view of big data as a panacea. Data—big or small—cannot be used as the only tool to answer a question.
With limited information at this point, it’s hard to see how FDA will leverage this focus in a timely and meaningful way, and what this will require from device makers. Government‘s “big data” initiatives have required significant industry investments and headaches, e.g. the Global UDI Database, the Sunshine Act. While this CDRH priority emphasizes leveraging data that is already being collected, but underutilized in regulatory decision making, device companies should push for greater understanding of the initiative. How and what data will be collected? What decisions will the data influence? Who will determine the meaningfulness of the correlations found in the data in order to determine whether or not a device meets the standards of safety and effectiveness?