Review by Joseph Ross – 05/03/2018 – 2:55pm

Data Request Number: 2018-3121 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 interesting analysis to compare induction of remission and other measures of treatment response among patients with moderate-severe ulcerative colitis, comparing treatment with of infliximab and golimumab. Any observation of treatment response will depend upon the frequency of follow-up during the clinical trials. It would help to provide a bit more detail as to how this will be handled (particularly if the trials use different periods of follow-up: ie, q4weeks vs q6weeks, etc). Moreover, I was surprised that the investigators are not taking advantage of time-to-event analyses, as opposed to using multivariable logistic regression, given the study question. Was there a particular reason why not? Hopefully, addressing these aspects of the proposal will strengthen the investigation.

Recommendation for this data request: Approve