Review by Joseph Ross – 11/28/2017 – 3:47pm

Data Request Number: No Data Request Assigned 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):

This is an intriguing proposal using matrix decomposition to predict likelihood of future adverse events based on prior adverse reactions. However, I am concerned that the investigators are biasing their results by excluding patients who have very few or no adverse events. They should consider the impact of this exclusion on the generalizability of their findings to a real-world patient population. In addition, I was surprised by the limited number of covariates being used in the modeling (no information on patient co-morbidity, concomitant medication use, etc.). Finally, will the model results obtained from analyses on one trial be validated in another trials’ patient population? Or will the 4 trials samples be combined for matrix decomposition analyses?

Recommendation for this data request: Approve