The evidence base supporting treatment interventions for patients with disorders of consciousness is limited, and rigorous treatment trials are needed to guide future management of this complex patient population. There are many potential study designs that can be employed to develop this evidence, but the process of selecting the optimal study design is challenging. This article reviews common obstacles that impede research progress in this population and a range of study designs that may be employed. In addition, we consider how the particular practical and scientific obstacles may drive selection of the optimal design and, in particular, how the optimal design changes as treatment research proceeds along the translational continuum from mechanistic discovery to real-world clinical impact.
Keywords: clinical trials; disorders of consciousness.