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