Methodological Support for a DiGA Project

A provider of a digital health application sought to have its product listed in the DiGA directory of the Federal Institute for Drugs and Medical Devices (BfArM). This requires a demonstration of the positive healthcare effect in a comparative clinical study. Whether that proof succeeds depends heavily on the study design. If it is not set up appropriately, even an effective application may fail to demonstrate its benefit. We supported the company as an independent methodological authority on the client’s side, intensively in the initial phase and again later when the study results needed to be interpreted. It began with the selection of the clinical research organisation, followed by the study concept for the pilot and evaluation studies, sample size planning, the choice of endpoints, and the derivation of the difference at which an effect becomes noticeable for patients. We critically reviewed analysis plans, interim results and reports. At the centre were the questions that go beyond statistical significance. Does the control group reflect the reality of care, or do strict participation requirements create a particularly adherent comparison group against which hardly any effect could be demonstrated? How do adherence and dropouts affect the result? And how can a methodologically robust narrowing of the target group be weighed against the addressable market? Making that trade-off visible and calculable was one of the tasks for which the company brought us in.