Data Safety Monitoring Board
The Data Safety Monitoring Board (DSMB), consisting of three independent experts in oncology and immunotherapy, has been established. With start of the clinical trial, the DSMB will regularly meet to review and evaluate the accumulated data for patient safety, study conduct and progress, and, when appropriate, efficacy and make recommendations to the Project Management Board (PMB) concerning the continuation, modification or termination of the trial. The Data Safety Monitoring Board will also act as the Ethics Advisory Board (EAB). All ethical issues regarding research on humans, handling of personal data and information provided to patients will be discussed and addressed here.
HEPAVAC is proud to have the following distinguished Scientists as Members of the DSMB/EAB:
Prof. Giorgio Parmiani (Head), San Raffaele Hospital, Milan, ITALY;
Prof. Stefan Endres, Medical Faculty of the Ludwig-Maximilian University Munich
Prof. Pedro Romero, Ludwig Center for Cancer Research University of Lausanne, Switzerland.
Prof. Massimo Colombo, Fond. IRCCS Cà Granda Ospedale Maggiore Policlinico and University of Milan, Milan, Italy.
Dr. Tim Greten, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA