Review by Joseph Ross – 08/23/2018 – 12:41pm

Data Request Number: 2018-2711 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):

Interesting study to evaluate the prediction capacity of a model for Crohn´s disease severity/progress using drug dose and dosing schedule, as well as patient characteristics including key biomarkers such as initial cytokines levels. Key will be the availablity of the key biomarker data in the IPD and how reliably it was ascertained during patient follow-up.

Recommendation for this data request: Approve