Being Open Minded About Neuromodulation Trials: Finding Success in our “Failures”

Publication date: Available online 23 December 2016
Source:Brain Stimulation
Author(s): Joseph J. Fins, Cynthia S. Kubu, Helen S. Mayberg, Reinhard Merkel, Bart Nuttin, Thomas E. Schlaepfer
As part of the efforts of a multi-disciplinary, international working group focused on ethical issues in neuromodulation for neuro-psychiatric disorders, we propose a novel; strategy for study design which iteratively applies new knowledge to on-going and future trials. Under current practice, device studies may be closed or categorized as "failures" before knowledge embedded in them can be fully mined. We propose the use of an iterative process to gain knowledge from subjects who have responded to those who have not. This approach can help maximize outcomes in non-responders and inform the design of future studies. This more agile yet rigorous methodology leverages information at all stages of investigation and promotes both scientific discovery and; stewardship.



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