The H2O project is led by the pharmaceutical company TAKEDA and coordinated by the Medical University of Vienna (MUW).
Meni Styliadou, Distinguished Fellow, Data Sciences Institute, at Takeda Pharmaceutical and Tanja Stam, Head of Section for Outcomes Research – Center for Medical Statistics, Informatics and Intelligent Systems (CEMSIIS) at the Medical University of Vienna pilot the project.
H2O’s governance model promotes the active participation of hospitals, academia, patient organisations, pharmaceutical companies (EFPIA) and associated partners in order to achieve maximum collaboration and data sharing. The management structure of H2O has been developed to respond to the needs of an international large-scale multi-stakeholder project and it includes:
– General Assembly (GA) which integrates all partners and has the ultimate decision-making responsibility in matters affecting the overall project strategy and composition of the Consortium.
– Steering Committee (SC) which is formed by work package and the Country Coordinators (CC) where the observatories will be first implemented. The SC is responsible for decision making on matters affecting the overall execution of the project.
– Executive Committee (ExCom) which consists of the leaders of the public and the industry consortium and is in charge of the overall scientific leadership of the project and strategic oversight.
– Country Coordinators (CC) in Austria, Germany, Netherlands and Spain (one public and one EFPIA) are responsible for ensuring the successful implementation of H2O and, in particular, of the Observatories as part of the national ecosystem.
– Coordination and Management Office (CMO) which is integrated by the Scientific Coordinator and the Project Managers and focuses on the day to day operations.
– Data Management Officer (DMO) which participates in the definition of the data management governance and workflows and monitors the management of data collection and quality control performed by different partners in H2O. Charité leads the DMO with the support of i~HD.
– Advisory Boards composed by recognised external experts in ethical, regulatory, patient and scientific and technical aspects. Patients specifically are represented in the three disease-specific Patient Advisory Boards (PABs).