Qualification opinion of a novel data driven model of disease progression and trial evaluation in mild and moderate Alzheimer’s disease
European Medicines Agency, Qualification opinion of a novel data driven model of disease progression and trial evaluation in mild and moderate Alzheimer’s disease, EMA/CHMP/SAWP/420174/2013, www.ema.europa.eu 
Ongoing public consultation. Qualification opinion, model of disease progression, mild and moderate Alzheimer’s disease. On 20 March 2013 the Applicant Critical Path Global Ltd. requested qualification opinion for the 18 proposed Disease Progression and Trial Evaluation Model.
The context of use: “The proposed disease progression and trial evaluation model, as defined in this document, is suitable for qualification for use in drug development as a longitudinal model for describing changes in cognition in patients with mild and moderate AD, and for use in assisting in trial designs in mild and moderate AD.” The intended scope and use for the drug development tool presented in this application are as follows: General area: the goal is for this tool to serve as a resource for sponsors designing trials across the Alzheimer’s community. It is intended that sponsors will utilize this simulation tool to provide a quantitative rationale for selection of study design and inclusion criteria. This tool could also be utilized by sponsors and health authorities for comparison of post-hoc analysis results to historical controls (priors) to minimize false positives.
