Unmet Needs and Challenges in Clinical Research of Intracerebral Hemorrhage
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Over 2.3 million people suffer hemorrhagic forms of stroke (intracerebral hemorrhage [ICH] and subarachnoid hemorrhage) worldwide every year; two-thirds survive with permanent disabilities.1 Unlike its ischemic counterpart, the incidence and morbidity of hemorrhagic stroke have not declined over recent decades, and rates are substantially rising in Asia, and low- and middle-income countries.1 There is considerable need for effective therapies to improve outcomes from hemorrhagic stroke, in particular for its most common subtype, ICH.
The first HEADS (Hemorrhagic Stroke Academia Industry) roundtable was convened in Baltimore, Maryland in May 2017. This collaborative one-and-a-half day meeting comprised leaders from academia, device, and pharmaceutical companies, the National Institute of Neurological Disorders and Stroke, and the Center for Drug Evaluation and Research Division of Neurology Products and the Center for Devices and Radiological Health Division of Neurological and Physical Medicine Devices of the US Food and Drug Administration, and the Center for Medicare and Medical Services. The meeting was modeled after the STAIR (Stroke Therapy Academic Industry Roundtable),2 and focused on ICH. Day 1 consisted of 4 sessions covering the following topics (1) translational challenges and therapeutic targets; (2) clinical trials—past and the future; (3) pharmaceuticals and devices in the pipeline; and (4) navigating the Food and Drug Administration, Center for Medicare and Medical Services, and National Institutes of Health regulations. Each session included a series of talks by experts in these areas, and a list of relevant challenges was formulated at the end of each session following an open group discussion. On day 2, participants were divided into 2 working subgroups, basic and clinical research. Each group was provided with a summary of emerging challenges from day-1 sessions and was tasked to define unmet needs and …