Review by Joseph Ross – 09/08/2021 – 7:11pm

Data Request Number: 2021-4778 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 a useful project to leverage data from multiple RCTs to compare the efficacy of adalimumab, ustekinumab, infliximab, and vedolizumab on endoscopic outcomes at one year on each ileocolonic segment among patients with Crohn’s Disease. Because these data all derive from different trials, and thus different trial populations, there is a risk of unmeasured confounding biasing the comparison. As in, some trials may be in younger patients, or sicker patients, or wealthier patients, etc. The investigators do not pre-specify the socio-demographic and clinical characteristics which will be used in their multivariable regression models to adjust for measured confounding. These should be clearly stated, including how missing data will be handled across the trials.

Recommendation for this data request: Approve