Alzheimer’s Plan Emphasizes Acceleration, Sets Timeline On Prevention, Cure
Ambitious draft plan from the Obama administration includes public/private efforts to shorten drug development times and pick up the pace of clinical trials, including more efficient ways of identifying and enrolling participants.
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Senator reiterates his support for Alzheimer’s research, but says the appropriations committee will not pay for it with money intended to support proven methods to prevent disease.
Disease communities will have to be engaged in developing endpoints needed to make accelerated approval happen for more drugs; FDA acknowledges that the pathway is “underutilized in many areas.”
A second failed efficacy trial, CONCERT, provided the final nail in the coffin for the once-promising treatment for Alzheimer’s disease, serving as a cautionary tale against excessive enthusiasm for early clinical trial results.