Figure 2: Prototypical sequence for planning and conducting a clinical trial
Clinical trials on and with sick or healthy persons constitute the cornerstones of healthcare within the meaning of an evidence-based medicine in constant flux. On the one hand, this applies to the marketing authorisation of medicinal products, medical devices or digital health apps. On the other, this also applies to the development and updating of clinical practice guidelines. This scheme illustrates the complexity involved in planning and conducting such clinical trials. The red boxes indicate the time-consuming processes that would benefit from a reduction in bureaucratic red tape.
Legend: BOB=Bundesoberbehörde, higher federal authority, IP=intellectual property; KKS=Coordination Center for Clinical Trials, ZKS=Center for Clinical Trials Tübingen, TLE=Trial Evaluation Center
Source: Lecture B. Lang at the Berlin Forum, KKS Network (Association of Academic Coordinating Centres for Clinical Studies in Germany, https://www.kks-netzwerk.de/en/network/about-us/)