Statistics Collaborative, Inc. (SCI) has worked on many trials in neurology studying a diverse group of diseases. Efficacy outcomes pose special problems in several of these diseases because many of the outcomes are scales such as the neuropsychiatric inventory (NPI), the Hamilton Depression Scale (HAMD), or the NIH Stroke Scale (NIHSS).
Alzheimer’s disease: SCI has served as the independent statistical group reporting to Data Monitoring Committees (DMCs) for trials of novel therapies that operate differently from the standard acetylcholinesterase inhibitors.
Stroke: In several trials we have served either as a member of the DMC or as the independent statistician reporting to the DMC. We have helped a client develop a trial using hypothermia as a method of treatment for stroke patients.
ALS: For a small biotechnology company with expertise in neurological disease, we helped develop Phase 1, 2, and 3 trials as well as compassionate-use studies. We worked closely with the director of medical affairs, the in-house statistician, and outside investigators.