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Use of clinical staging in amyotrophic lateral sclerosis for phase 3 clinical trials.

Rubika BalendraAshley JonesNaheed JivrajI Nick SteenCarolyn A YoungPamela J ShawMartin R TurnerP Nigel LeighAmmar Al-Chalabinull null
Published in: Journal of neurology, neurosurgery, and psychiatry (2014)
We have shown using trial data that transition times between stages are short. Use of stage duration as an endpoint might allow a shorter trial duration. We have shown face validity in this system as most patients progress through consecutive stages, and none revert to earlier stages. Furthermore, we have shown the system is reliable across populations and therefore has content validity.
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