Review by Joseph Ross – 12/24/2020 – 1:53pm

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 have proposed to investigate whether serum cytokines can predict the outcomes to ustekinumab treatment in patients with Crohn’s disease. However, the methods of this analysis are not clear. The investigators have examined that receiver operating curves (ROC) will be generated for each outcome of interest: 1) CDAI less than 150 at week 8, week 16, week 52 and 2) CDAI decrease of 100 or more, and that the AUCs will be compared between groups. However, the groups are not clearly defined. I presume the two groups are those that received ustekinumab and those that received placebo. Correct? But also, how will this assess the association of serum cytokines and outcomes of treatment? Is there a plan to use a measure of serum cytokines that has not been described? Nor are any other variables proposed for use in this analysis. Please clarify.

Recommendation for this data request: Not Approve