Review by Cary Gross – 12/26/2020 – 10:06am

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?: 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):

The investigators propose to determine whether baseline cytokines can “predict outcomes to ustekinumab treatment”. However, their analytic plan, as written, will not address this aim. For instance, the independent variable is incorrectly specified, the manner in which treatment assignment group (i.e. ustekinumab or control arm) will be incorporated into the analysis is not mentioned, and the construction and analysis of the model is incomplete, mentioning only that AUC curves will be compared.

Recommendation for this data request: Not Approve

incomplete and vague analytic plan