National recommendations for registry-based randomised clinical trials (R-RCTs)
Registry-based randomised clinical trials (R-RCTs) are defined as prospective randomised studies that to some extent use registries for their implementation. For example, registries may be used for screening and recruitment, to provide background data on the population, and to collect endpoint measures and results. Here registries refer primarily to quality registries in healthcare, but the methodology is also applicable to other systems that are used in a structured way for documentation of patient data.
Together with leading experts in the field, Clinical Studies Sweden has developed national recommendations in the form of documentation and a technical framework. The goal of these is to facilitate and support the work of new R-RCT studies in the existing Swedish quality registries and other appropriate registries and data collections.