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44 – Trial Design and Analysis Issues in Medical Devices
On Weighted Performance Goals in Medical Device Single-Arm Clinical Studies
Nelson Lu
Center for Devices and Radiological Health, US Food and Drug Administration
Yunling Xu
Center for Devices and Radiological Health, US Food and Drug Administration
Under some circumstances, a pre-market application of medical devices may be supported by a single arm study where clinical endpoint is compared with a performance goal (PG). Occasionally, performance is expected to be different between two clinically defined subgroups of patients, and an approach based on a weighted PG is adopted. In this article, we discuss considerations of current practice where weights need to be pre-specified and fixed. We also propose an approach which relaxes the fix weights requirement.