Ethics and Bias in Clinical Trial Enrollment in Stroke.

Abstract

To familiarize the reader with ethical concerns and potential scientific bias in management and conduction of clinical stroke trials. The goal of clinical trials in stroke is to find effective interventions for stroke prevention, acute treatment, and rehabilitation and recovery. Acute trials must be designed in the context of the time-sensitivity of revascularization therapies. Standard ethical constraints apply. However, informed consent is hindered by tight time windows for reperfusion therapy and frequent cognitive impairment in patients. These might be mitigated by using visual decision aids. Non-traditional methods of consent such as utilization of surrogates, telemedicine, and exception from informed consent are critical for successful and unbiased conduction of stroke trials. Stroke centers must have an a priori plan for deciding which trial to offer multiple-trial eligible patients. Historic non-generalizability of stroke trials due to under-enrollment of women, racial minorities, and age extremes is improving, but adequate representative recruitment and retention require up-front planning and training. Stroke trials have become less biased and more representative in the last decades, but there is still research to be done to improve ethical and unbiased recruitment and retention.