The shift to increased patient input for device development and clinical trials in recent years has been more challenging than expected, according to participants at the FDA/CMS Summit.
As part of a shift by the FDA to patient-centered care that began in 2011, the agency set a goal of increasing its engagement with patients and it is now 96 percent patient-engaged, according to CDRH Director Jeff Shuren.
The percentage of FDA-approved clinical trials that include patient-reported health outcomes has now reached 80 percent, Shuren said.
Patient data that can be collected and analyzed for reducing inefficiencies or driving policy goals relate not only to the attributes of the devices, but also the tradeoffs the patients can accept. For example, the FDA approved the first portable hemodialysis device, NxStage’s System One, this summer after study results showed patients were willing to take on the risk of using a dialysis machine by themselves, Shuren said.
The cost of patient studies can be an obstacle. Jamie Sullivan, vice present of public policy and outcomes at the COPD Foundation, pointed out that an IRB approval for a patient study can sometimes cost $1,000 or more and the process can take weeks to complete.
This may not be an issue for larger firms, but it may make conducting studies aimed at understanding a patient population nearly impossible for smaller firms, said Barry Liden, vice president of patient engagement at Edwards LifeSciences.
Another major challenge for patient groups and device firms has been getting health insurance companies more involved in patient data collection. Panelists said it has been very difficult to get payers involved unless there is a discussion around what’s in it for them — reducing hospital readmissions, for example.