The FDA is working to bring patients’ perspectives to its process of evaluating microinvasive glaucoma surgery (MIGS) devices, according to Tieuvi Nguyen, PhD, chief of the agency’s Intraocular and Corneal Implants Branch.
“The next step . . . is to find ways to incorporate the patient’s voice,” said Dr. Nguyen in a panel discussion at the 6th annual Glaucoma 360 New Horizons Forum.
Two years ago, the FDA and the American Glaucoma Society (AGS) convened to discuss the best clinical trial design for MIGS. That process resulted in new guidance promulgated Dec. 15, 2015, Dr. Nguyen said.
In addition, on Aug. 24, 2016, the agency issued guidance on using patient preference information.
This information informs endpoints or effect sizes for regulatory studies, subgroup considerations and labeling changes or expanded indications, Dr. Nguyen said.
In addition, the agency is trying to make more use of patient-reported outcomes for regulatory studies and post-market monitoring in a way that is useful to payers, providers, and patients themselves, she said.
Submissions that include patient-reported outcomes have increased significantly in recent years, both in total numbers and as a proportion of those submissions that got approved, Dr. Nguyen said.
The FDA is collaborating with “centers of excellence in regulatory science and innovation” in a program that currently includes the University of Maryland, Georgetown University, Johns Hopkins University, the University of California, San Francisco (UCSF), and the Yale-Mayo Clinic.