Patients & carers consider speech one of the most important features of disease

The ALS Association conducted their ALS Patient-Focused Drug Development survey, a parallel effort to the U.S. Food and Drug Administration’s Patient-Focused Drug Development Initiative to explore treatment priorities for patients. Individuals with ALS and caregivers of individuals with ALS reported [in order of priority] significant symptoms of fatigue and weakness, followed by speech problems, shortness of breath, difficulty sleeping, and pain [data from 887 people with ALS, 448 caregivers of living individual with ALS, and 193 of caregivers of individual with ALS who has passed away]

Understand what clinical outcome assessments mean for your trial

Redenlab have experience in FDA Type C meetings and EMA CHMP meetings for determining suitability of clinical outcomes for efficacy trials. They appreciate COA are not all equal and study phase can determine the suitability of one outcome over another. Let Redenlab help you nagivate this challenging stage of drug development.