Digital Health-Enabled Clinical Trials in Stroke: Ready for Prime Time?

ABSTRACT

As stroke continues to represent a major global health care problem, advancing our knowledge of new effective and safe stroke interventions represents a public health priority. The identification of these therapies requires the conduct of high-quality and well-powered randomized clinical trials. Despite its potential to inform clinical practice, traditional randomized clinical trial models have their drawbacks, including elevated costs, long completion times, failure to recruit the target sample sizes, lack of diversity, and complex operational procedures. Therefore, improving the participants' experience and trials' overall efficiency constitutes an important unmet need. Innovative models such as virtual and decentralized patient-centric trials have been proposed as a valuable strategy in this pursuit. In this narrative review, we discuss the limitations of traditional randomized clinical trial models and present the concept, advantages, and challenges of decentralized digitally enabled approaches to the conduct of stroke clinical trials.