Enrollment of research subjects through telemedicine networks in a multicenter acute intracerebral hemorrhage clinical trial: design and methods.

BACKGROUND Enrollment of subjects in acute stroke trials is often hindered by narrow timeframes, because a large proportion of patients arrive via transfers from outside facilities rather than primary arrival at the enrolling hospital. RATIONALE Telemedicine networks have been increasingly used for provision of care for acute stroke patients at facilities outside of major academic centers. Treatment decisions made through telemedicine networks in patients with acute ischemic stroke have been shown to be safe, reliable, and effective. With the expanding use of this technology and the impediments to enrolling subjects into clinical trials, this approach can be applied successfully to the field of clinical research. METHODS AND CONCLUSIONS The Antihypertensive Treatment of Acute Cerebral Hemorrhage II trial is a phase III randomized multicenter trial that has developed a protocol in collaboration with participating sites to implement the use of telemedicine networks for the enrollment of research subjects. The protocol describes the operating procedures and legal and Institutional Review Board perspectives for its implementation.