Review by Joseph Ross – 12/19/2016 – 10:59am

Data Request Number: 2016-1176 Is the scientific purpose of the research proposal clearly described?: Yes Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: Yes Can the proposed research be reasonably addressed using the requested data?: Yes, or it’s highly likely Please use this space to provide any comments, feedback or concerns (optional):

Research proposal describes use of data from UNITI-1, UNITI-2 and IMUNITI – however, only data from latter 2 were requested.
Investigators are applying a patented algorithm to existing data. Must be clear that goal of YODA Project is to generate broad scientific knowledge. Results must be published, cannot be used for commercial purposes in order to generate ThioMon profit.
The methods did not clearly specify how the Immunosuppression Score was calculated, just the data that was used to calculate the score. Please provide details.
I was surprised by the limited number of variables being considered for use in the machine learning-based algorithm. I would have thought an unsupervised approach would have used, taking advantage of a larger number of data elements, as opposed to the handful pre-specified by the investigators based on clinical experience. No changes are necessary, unless they’d simply like to provide more details.

 Recommendation for this data request: Approve