Adaptive Designs in Fast-Track Registration Processes for Digital Health Applications

Fast-track procedures play an important role in the context of conditional registration of medical devices, such as listing processes for digital health applications. They offer the potential for earlier patient access to innovative products and involve two registration steps. The applicants can apply first for conditional registration. A successful conditional registration provides a limited funding or approval period and time to prepare the application for permanent registration (the second registration step). For conditional registration, products have to fulfill only a part of the requirements necessary for permanent registration. There is interest in valid and efficient study designs for fast-track procedures. This will be addressed in this paper. A motivating example is the German fast-track registration process of digital health applications (DiGA) for reimbursement by statutory health insurances. The main focus of the paper is the systematic statistical investigation of the utility of adaptive designs in the context of fast-track registration processes like the DiGA fast-track. We demonstrate that, in most cases, such designs are much more efficient than the current standard of two separate studies. A careful statistical discussion of the registration requirements and their consequences is also included. The results are based on numerical calculations supported by mathematical arguments.