Review by Cary Gross – 01/24/2021 – 11:29am

Data Request Number: 2020-4499 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?: Unsure, further clarification from requestor is needed Please use this space to provide any comments, feedback or concerns (optional):

The investigators were responsive to the prior comments. However, they still have not described how they will select which cytokines are associated with clinical improvement, and once they have ascertained a group of cytokines that are associated with improvement, how might that group of cytokines be used in the final model? Is the idea to determine which cytokine has the strongest association with outcome? Or to identify a “panel” of cytokines that would be used concomitantly, as a sort of index?  And for each of these options, if they are a goal of the study, how would it be accomplished analytically?

Recommendation for this data request: Not Approve

see above