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  1. Advancing Regulatory Science

Patient and Provider Views on Clinical Endpoints: A Qualitative Preference Study of Minimally Invasive Glaucoma Surgical (MIGS) Devices

CERSI Collaborators: Tianjing Li, MD, MHS, PhD, John Bridges, PhD, Jimmy Le

FDA Collaborators: Malvina Eydelman, MD, Michelle Tarver, MD, PhD (CDRH)

Project Start Date: January 2016

Regulatory Science Challenge

Glaucoma, a chronic eye disease that results in damage to the optic nerve and can potentially lead to blindness, affects over 2.7 million Americans. Increased pressure inside the eye is a contributing factor to glaucoma progression. Therefore, therapies such as eye drops, oral medications, laser therapy, and surgery are designed to lower this pressure. Recent innovation in glaucoma procedures has led to the development of minimally invasive glaucoma surgical (MIGS) devices, which may be safer than other glaucoma surgical procedures and reduce the need to use eye drops. Prior evaluation and clinical studies of these devices have not adequately incorporated patient perspectives into determining some-important clinical outcomes, such as health-related quality of life, function, and eye symptoms. Patient preference information can provide insight about the relative desirability and acceptability of the benefits and risks of therapies in managing medical conditions. Patient preference information, collected through the use of standardized and validated tools, can advance medical product development by improving device design strategies, informing clinical trial design and conduct, and enhancing regulatory reviews and post-market evaluation. A collaborative effort between FDA, JHU CERSI, UCSF-Stanford CERSI , and the American Glaucoma Society has been established to collect patient preference information on benefits and risks for MIGS devices.

 

Project Description & Goals

This project will involve glaucoma patients, their carepartners, physicians, researchers and regulators to define the essential characteristics for a framework to identify outcomes for MIGS clinical trials that are of direct importance to patients. Aims include (1) conducting in-depth interviews with patients who have mild to moderate glaucoma to further understand their perspectives; and (2) conducting a quantitative preference study to prioritize outcomes that matter most to patients. This project will provide key information about MIGS devices and how consumers can use this information to make informed treatment decisions. In addition, it will contribute to the rapidly developing methodological area of patient preference research and give insights into various ways that patient perspectives can be incorporated into regulatory decision making.