Purpose of the study: Prospective randomised controlled trials are accepted as gold standard of clinical research. For the comparison of two defibrillation techniques in an animal model of cardiac arrest we aimed to transfer this standard to preclinical research.
Materials and methods: Our goals for randomisation were its execution in a blinded manner that can be presented transparently in future publications. As primary variable we are interested in the first shock success rate. Following the 3R concept by Russel and Burch we aimed to add an adaptive design to reduce sample size to the lowest statistically justifiable level for our primary variable.
Results: To setup a new study our newly developed software requests: number of treatment arms, maximum sample size, its allocation, number of interim looks, levels of error for the final look. Blinded to the researchers our software creates based on these data a set of unique IDs for all cases. Each ID is assigned to one of the defibrillation techniques. When starting with a new animal the software randomly picks one of these IDs and hands the corresponding defibrillation technique over to the defibrillator that shows in “study mode” as sole option “defibrillation”. The number of defibrillations required is counted and transferred to our software’s database where first shock success rates are compared on interim looks. The software terminates the study when significant statistical differences between the groups are shown.
Conclusions: Our study is still ongoing and final results on the defibrillation technologies are pending. However, our software has yet shown its feasibility for the examination of medical technology. It facilitates randomisation and interim looks and improves scientific impact and animal welfare at the same time. Currently it’s limited to animal studies on medical technology.

Enhancing preclinical research by a software supporting randomised, blinded and adaptive study designs.