Maarten Cozijnsen

146 Successful completion of an investigator-initiated RCT in pediatric CD is challenging ITSKids and TISKids are investigator-initiated RCTs largely sponsored by the Netherlands Organization for Health Research and Development (ZonMw). ITSKids, the first of the two trials, was seized prematurely due to a low inclusion speed. An important reason for this low inclusion speed was the inadequacy of research funds to cover the costs of trial medication (especially infliximab at a cost of approximately €500.000 [50 Top-down patients, 5 infusions per patient, 2,5 vials per infusion, approximately €800 per vial in 2013]). Most of the funds were spent on PhD salary and other organizational costs. Because infliximab was not paid for in ITSKids when given top-down, many hospitals in the Netherlands and internationally, while initially supportive, in reality could not commit to the study. Only with sponsorship of a pharmaceutical company that provided the required infliximab biosimilar vials free of charge, the project could continue as TISKids with an adequate inclusion speed. Notably, the investigators remained in the lead in every aspect of the trial – the pharmaceutical company had/has no role in the study design, data collection, statistical analysis, interpretation, or writing of the report. The other challenge we faced, as stated above, was including the required number of patients within a reasonable timeframe. This is a challenge for most RCTs that include pediatric CD patients, as the risk of developing CD during childhood is limited. Getting a reasonable inclusion rate required us to collaborate with multiple hospitals in multiple nations, which complicated trial management. Multicenter research could be facilitated by creating networks of researchers that are properly organized and staffed to efficiently carry out multicenter trials.