The executive director of the Norman Fixel Institute for Neurological Diseases explained how disease-based registries play a crucial part in changing the approval system for neurologic devices in rare diseases.
A recently published viewpoint paper by Michael Okun, MD, and James Giordano, PhD, outlined the flaws within the approval process for deep brain stimulation and neurologic device approval in rare diseases. In efforts to balance the system out and allow these devices to have the same benefit that traditional drug development receives, Okun mentioned the increased use of disease-based registries.
He detailed that expanding this process would allow a university and/or foundation to submit a device master file as well as using the data to serve as a coapplicant for full FDA approval. This would ultimately decrease legal risks to industry and provide incentives to manufacturers, who commonly find investing in these devices to be “unattractive,” according to the paper. The hope is that these registries could satisfy the FDA-imposed conditions of approval contingencies reliant on long-term data.
Okun, executive director of the Norman Fixel Institute for Neurological Diseases, claims that if industry is incentivized to run these registries, there would be more cooperation across the board. He sat down with NeurologyLive to provide an in-depth explanation on why these registries could be potential game-changers, and what trickle-down effects they could have for clinicians and patients alike.