A statistical reviewer’s perspective on using sham as the control in neuromodulation device studies
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*Martin Ho, Center for Devices and Radiological Health 

Keywords: Blinding, Neuromodulation Device, Medical Devices

Blinding is a critical part of the design of medical device trials. It preserves the integrity by preventing bias introduced by patients, physicians, evaluators, and treatment allocations. Researchers face a range of challenges in designing the blinding mechanism of neuromodulation device trials with sham as the control. I will provide some examples to illustrate what roles the design and assessment of blinding play in establishing the safety and effectiveness of neuromodulation devices from a statistical reviewer’s perspective.