A statistical reviewer’s perspective on using sham as the control in neuromodulation device studies
View Presentation *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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC