Newsbeat: Bucket Benefits

Reprinted from PN/Paraplegia News November 2015

The viral Ice Bucket Challenge is seeing some key research for people with ALS

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All those buckets of ice water are resulting in some key research for people with amyotrophic lateral sclerosis (ALS). The ALS Association announced in September that “a critical effort made possible by the ALS Ice Bucket Challenge” is underway. The effort involves almost 100 people with ALS, caregivers, researchers, clinicians and industry experts to create drug development guidance designed to accelerate the development of therapies to slow or stop ALS.

The guidance, which will be submitted to the Food and Drug Administration (FDA), will serve as a roadmap to help companies navigate the development process and provide the FDA with an ALS community-centered view of how it should approach therapies for the disease.

The goals are to make the drug development process, including clinical trials, more efficient, predictable, faster and effective at assessing drug efficacy. This will speed up access, reduce costs, help ensure resources are most effectively utilized, and incentivize industry to enter the ALS market and develop new treatments for ALS.  
The group will focus on seven specific areas of ALS drug development and provide an ALS community-wide view on topics that include diagnosis, natural history, clinical trials and outcome measures, biomarkers, benefit-risk, frontotemporal dementia and public policy.

The draft guidance will be posted for public comment in February or March of next year, then submitted to the FDA for review.

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Newsbeat: Bucket Benefits


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