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Abstract:
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Technologically advanced therapeutic medical devices, such as cardiovascular pacemakers or neurostimulators, provide a valuable option for patients when standard treatments are inadequate. Demonstration to regulatory authority is based on providing valid scientific evidence that the device is safe and effective. In earlier days of the medical device industry, single-arm studies were the usual design in device clinical trials. More recently, concern has been expressed regarding placebo effect, where patient outcome may be influenced by belief that device therapy is effective. There has been discussion about the design of a placebo control arm, including ethical, practical, and scientific aspects. This talk will give a historical description of the debate and present specific examples of placebo controls. Statistical design issues and possible strategies will be discussed.
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