Clinical translation in central nervous system diseases: Ethical and social challenges

Abstract

The entire trajectory of neurological research is rife with uncertainty and risk. Despite the abundance of new molecular targets, therapeutic platforms, and increasingly sophisticated theories of pathophysiology, drug development in neurology remains a failure-prone endeavor. This risk, and its reciprocal opportunity, is thick with ethical and epistemic challenges. Given the low likelihood of demonstrating clinical utility and the devastating impact of neurological disease, what neurological interventions should be investigated? What level of evidence provides a warrant for exposing nonhuman animals and human beings to burdensome and often invasive strategies? This chapter examines some of the ethical and social dimensions of translating new neurological interventions from laboratory concept into various stages of clinical development, focusing on the dominant ethical and epistemic issues as they emerge (and reemerge) throughout the knowledge production process. It concludes with a brief discussion of several relatively uncharted ethical and epistemic questions as they pertain to CNS clinical translation.