Update on active clinical sites, patient enrollment and regulatory processes
As a multicenter, prospective study, SHIELDS involves eight European sites, spread across Belgium, France, Germany, Italy and The Netherlands. Currently, 7 sites have been activated ready to enroll patients. In Figure 1, an overview of SHIELDS’ participating clinical centres and DSMB members can be found.
In our previous newsletter, we announced that enrollment in Germany would continue after the National Competent Authority (BfArM) has positively evaluated the seven-day follow-up report from the fist 10 patients. In the meantime, we received approval from BfArM to continue and 16 patients have been enrolled in Germany to date (7 in Oldenburg, 7 in Hamburg, 2 in Gottingen). Unfortunately, still restricted by strict COVID-19 regulations, no patients have yet been enrolled for the study in Berlin.
In total, 23 patients have been enrolled to date (11 liver and 12 pancreas). In addition to the 16 patients enrolled in Germany, 5 have been enrolled in Italy, 1 in Gent and 1 in Amsterdam. Our French site (Lyon) is under review by the relevant authorities and final approval is anticipated shortly
Based on recent communications with on-site teams regarding enrolment rates, we anticipate that the complete study population (N = 80; of which 40 liver and 40 pancreas patients) should be finalized by the end of April 2021.