Design Considerations in Medical Device Clinical Trials for Chronic Conditions
*Sarah Hurwicz Kogut, i3 Statprobe 

Keywords: medical device, clinical trial, placebo, sham device

Medical devices have been used to treat medical conditions including chronic pain or depression when standard treatments have not been successful. It has been suggested that for such indications, there could be a strong placebo effect if patients hope or expect to benefit from the medical device. Randomized double-blinded placebo-controlled clinical trials would be recommended to assess whether the treatment offers more benefit than only the placebo expectations. However, ethical as well as practical considerations can result in hesitancy to include a surgically implanted sham device as a comparison to the medical device treatment. This talk will give some examples of device clinical trials for chronic conditions which included a placebo comparison and describe how they were designed to address the challenges, as well as consider the future for this area of research.