What Kind of Trials are Envisioned?

Robert Silbergleit MD is a Professor of Emergency Medicine at University of Michigan. He graduated from MIT and the University of Michigan Medical School, completed his residency in Emergency Medicine at the Medical College of Pennsylvania, and trained as a research fellow at the George Washington University. Past research involved preclinical models of traumatic and ischemic injury, and clinical investigations in acute stroke care. His current research focuses on confirmatory phase clinical trials of acute interventions for neurological and cardiac emergencies. He is currently a Principal Investigator of the Clinical Coordinating Center for the NIH (NINDS. NHLBI, and NCATS) funded SIREN Emergency Clinical Trials network, as well as a PI for ICECAP, a national multicenter adaptive clinical trial of hypothermia duration in comatose survivors of cardiac arrest. He has also been a PI for RAMPART and ESETT, two national multicenter large randomized controlled clinical trials of treatments for acute status epilepticus. Dr. Silbergleit also currently contributes to the leadership of the ongoing BOOST, HOBIT, and C3PO clinical trials. He has served in the leadership of several other large trials including ProTECT and ATACH, and the Neurological Emergencies Treatment Trials (NETT) network, the predecessor of SIREN. Dr. Silbergleit is dedicated to improving the structure and efficiency of the clinical trial enterprise. He has been a co-investigator on a regulatory science grant from the NIH and FDA to investigate adaptive clinical trial methods in confirmatory phase trials. He also has expertise in clinical and research ethics. He is vice-chair of the Michigan Medicine Research Ethics Committee, and a long-standing member of the Clinical Ethics Committee. He has written and presented extensively on the ethics and regulation of planned emergency research. He is the Principal Investigator on an NIH funded empirical ethics research project to study local context review by individual and centralized Institutional Review Boards, and an NIH funded supplement on paramedic, investigator, and patient family experiences in emergency research and clinical care. He has served as an editor or reviewer for numerous journals. He has served on several NIH study sections and special emphasis panels, and has served as a reviewer, advisor, or participant for numerous other FDA, NIH, and other Federal review panels, advisory groups, or workshops. He has authored over 100 peer reviewed articles and commentaries, and 17 book chapters.