Towards a standardized protocol for conducting randomized clinical trial for software

Abstract In the last decade, evidence-based medical practice has been aided on a large scale by computerized decision support tools, aimed at reducing diagnostic and therapeutic uncertainty, complementing the actions of the health professional. With the technological evolution, it is already possible to consider these systems as part of the clinical intervention, both for the diagnostic stage and for the treatment of diseases. This article proposes the creation of a specific clinical trial protocol to evaluate the effects of the software as clinical intervention in different medical settings. The proposal is unprecedented and extremely relevant in the scientific literature and able to standardize from the development stage to the application of the software aiding in the treatment of diseases.