Review by Joseph Ross – 05/19/2020 – 6:00pm

Data Request Number: 2020-4275 Is the scientific purpose of the research proposal clearly described?: No If no, please explain:

Data are only made available via the YODA Project for scientific purposes. As best as I can tell, the investigators would like to use data to improve & validate their commerically-available prototype ADAS-Cog 11 model and develop & validate ADAS-Cog 13 & MMSE models. This would appear to be work for a commercial purpose, not a scientific purpose. The scientific purpose of this work, and commitment to disseminate knowledge gained, should be clarified.

Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: Unsure, further clarification from requestor is needed Can the proposed research be reasonably addressed using the requested data?: Unsure, further clarification from requestor is needed Please use this space to provide any comments, feedback or concerns (optional):

There are a number of confusing aspects of this application, which proposes to improve & validate our prototype ADAS-Cog 11 model and develop & validate ADAS-Cog 13 & MMSE models. Chief concern is that the authors do not specify how they will make use of the 3 clinical trials being made available via the YODA Project, but instead discuss their use of data being made available from the Critical Path Institute, including the CAMD and ADNI datasets. Investigators explain that selected participants must have longitudinal a record, baseline ADAS-cog & MMSE, date of onset and date of diagnosis – are these data points available for the 3 trials? The research proposal should be tailored to the data being requested. My guess is that the CAMD and ADNI datasets are being used for development, these 3 trials for validation. But if so, how will the results be compared? Will the CAMD and ADNI data sets be uploaded to the virtual environment used by YODA Project, or kept separate? Have the predictor variables been identified yet? They should be pre-specified.

Recommendation for this data request: Not Approve