The main purpose seems to be commercial rather than to create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health.Not Approve
As I understand it, the aim of this proposal is to create a predictive subclassification of Alzheimer’s disease which could prospectively identify subgroups for AD drug trials. “The objectives of this grant are to improve the prototype ADAS cog model, develop a Mini-Mental State Examination (MMSE, another common AD trial endpoint) model, validate the models with external datasets, make them accessible to clinical trialists through our API, and create several applications for AD drug development using the models, including enrichment, randomization, covariate adjustment and virtual controls. The applications will be made ready to use in AD clinical trials.”
Each of these elements should be separately contestable for this model to have real scientific validity. I am not sure how this is going to be achieved.