During the past few years, Investigator Sponsored Studies (ITT) have been the focus of growing attention in the field of cardiovascular medicine. This is because they have several distinct characteristics that make them well adapted to contemporary clinical research. Since there is no direct industry sponsoring, the investigator and the trial data are rightly viewed as independent. Off-label applications are easier to explore, and some regulators accept ITT in support of product approval. Co-sponsoring of a project can be implemented (for example a device and a pharma company can both contribute to funding the evaluation of a new combined drug & stent strategy).
ITT require an ad hoc structure to act as the legal sponsor of the project, since the investigators themselves are seldom in a position to do so, and any CRO that is contracted to run the trial cannot simultaneously be its sponsor. After preliminary discussions with its industry partners, CERC therefore decided to set up a structure that would meet these needs, and FERIC and CERIC were recently created.
FERIC is a non-profit Swiss Foundation that owns CERIC, an independent limited company which acts as the direct sponsor of clinical trials and is funded by grants from the industry. We are very happy that this new structure is now operational, and look forward to interacting with it increasingly in the future. Currently more than 5 trials are conducted very effectively thanks to this non-profit organisation, which also allows the collaboration of 2 or more CRO’s for a single trial.