Editor's note: Lauren Fusfeld is director at research and consulting firm Veranex. She can be reached at firstname.lastname@example.org.
For people with Type 2 diabetes mellitus, early identification of individuals at risk of diabetic kidney disease or a rapid decline in kidney function is an important step for optimal patient management and improved patient health outcomes, such as slowing or preventing disease progression. Nevertheless, traditional tests of kidney function are insufficient for predicting kidney disease and decline.
To address this unmet need, a medical technology company developed and validated a blood-based test that incorporates biomarkers to predict the risk of kidney disease/decline. The firm sought to demonstrate to physicians and payers the test’s clinical utility, defined as the extent to which the test affects physicians’ monitoring and treatment decisions.
The key question was the following: Would U.S. physicians change their medical recommendations to align with patient management guidelines if they had access to the results of this blood-based biomarker test?
Traditionally, companies have relied on prospective clinical studies to establish clinical utility. The downside of using a clinical study for initial research, however, is that such studies require significant resources, costs and time. The pandemic made finding a remote approach to assessing clinical utility increasingly important.
The medical technology company engaged our team of researchers to identify an effective and efficient methodology for demonstrating clinical utility. Based on a detailed understanding of the company’s needs, we suggested conjoint analysis, an approach recommended by the International Society for Pharmacoeconomics and Outcomes Research for this type of investigation.1, 2 This study design has been utilized to understand preferences of patients with Type 2 diabetes mel...