Challenges in Peripheral Artery Disease Clinical Trial Implementation and Design.

Abstract

There remain significant gaps in clinical evidence in the management and treatment of peripheral artery disease (PAD). Many of these gaps exist as a result of ongoing challenges that exist in the implementation and design of clinical trials within the PAD clinical space. These challenges include the often-fragmented state of PAD clinical care, the frequent coexistence of other cardiovascular disease states, difficulties with recruiting PAD patients into clinical trials, a lack of diversity within PAD clinical trials, the limited focus of PAD clinical trials, and the sparse validation evidence of secondary endpoints and patient-reported outcomes measures in PAD trials.