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MUSC joins neurological response effort by Cindy Abole Public Relations Establishing responsive new therapies and treatments for patients suffering from neurological emergencies is the focus of a recently established National Institute of Neurological Disorders and Stoke (NINDS) network.      MUSC joins the University of Michigan and 11 medical institutions across the country in sharing expertise to establish new treatments for patients diagnosed with severe neurological conditions through the National Neurological Emergency Trial (NETT) network. The Department of Biostatistics, Bioinformatics and Epidemiology’s Data Coordination Unit (DCU) successfully completed a five-year National Institute of Health grant award to serve as the statistical and data management center for the NETT. The University of Michigan will serve as the clinical coordinating center.   The NETT network was organized as a national multi-center project involving emergency physicians, neurologists, neurosurgeons and other experts at 11 medical institutions across the country. The network supports a 2004 NINDS-led effort to study effective treatment of neurological emergencies including stroke, traumatic brain injury, status epilepticus and Bell’s Palsy.      “This is a great opportunity,” said Yuko Palesch, Ph.D., director of the DCU. “We’re fortunate to be part of this network. It’s very exciting.”   The DCU will collaborate with Michigan to set up the network infrastructure for two NINDS-funded projects during a five-year period. Michigan will serve as the study’s clinical coordinating center and provide project management, regulatory guidance and administrative support to the network. The 11 emergency departments who successfully competed as the patient recruitment centers and include: the Medical College of Wisconsin, University of Pennsylvania, University of Minnesota, University of Arizona, Temple University, University of California, San Francisco; University of Kentucky; University of Cincinnati, Wayne State University; Henry Ford Health System in Detroit and Emory University.   “Our goal is not to ‘reinvent the wheel’ as it relates to clinical trial coordination and data management,” said Valerie Durkalski, Ph.D., associate director of DCU and the co-principal investigator of the MUSC NETT grant. “This NETT grant will help us focus on clinical studies in emergency medicine and clinical research and our ability to conduct clinical trials simultaneously among different patient populations. Our challenge will be managing how each of the 11 sites participate. We’ll provide a process that will eventually build economies of scale.”      Both Palesch and Durkalski see the NETT network as another opportunity for the DCU team to add a feather of expertise and experience in their cap. The DCU manages more than a dozen projects, including a number of stroke trials funded by NIH/NINDS.   The DCU team hopes to draw upon a number of campuswide colleagues for their expertise in this collaborative effort including biostatisticians, health economists, epidemiologists and clinical specialists.   “Much of this network focuses on challenges in conducting clinical trials in an emergency setting,” Palesch said. “This is the first time we’re working with emergency department staff and paramedic personnel and the nature of this setting is all new to us.”        The network will kick off with participation in the ongoing Albumin in Acute Stroke (ALIAS) study this summer. The ALIAS study is a multi-center, randomized Phase III trial to elevate the putative neuroprotective effect of albumin in acute ischemic stroke patients who can be treated within five hours of symptom onset. This study will afford the NETT investigators an opportunity to showcase the network. ‘Big picture’ data a key ical trials success  Helping to prove the efficacy of a clinical intervention, or new treatment that benefits the patient as part of a clinical study is the job of health economist Patrick Mauldin, Ph.D., associate professor, College of Pharmacy and co-investigator of the MUSC NETT grant.   Mauldin, whose expertise is in economic evaluations, outcomes research, econometrics and digestive, neurological and infectious disease.   When an outcome is not so clear regarding the efficacy of a new treatment or drug that is being reviewed, a health economist can provide valuable data.      As part of the Neurological Emergencies Treatment Trials’ Rapid Anticonvulsant Medication Prior to Arrival (RAMPART) trial, study leaders must decide if an economic component is needed in studying the effectiveness of an anti-seizure drug used with status epilepticus patients and how it’s delivered during a neurological emergency.     Mauldin looks at the big picture and tries to compare the expected costs to the patient, hospital, health care provider and payer between new versus standard treatments; what medical resources are used by the patient; and during what stage of their treatment and/or recovery.      “An added value of economic evaluations is the ability to measure patient’s resource utilization during their recovery outside of the hospital setting,” said Mauldin, who has collaborated with the Data Coordinating Unit on several grant projects.      The role of health economists and other specialists in clinical trials research is on the rise thanks to the growth of more NIH-funded clinical trials. This aspect of information has become important in clinical trials work, Mauldin said.      “It would be nice if every new clinical intervention that was effective could be quickly provided to patients,” Mauldin said. “But because we live in a world of limited resources, costs need to be considered in most cases.”     Friday, April 13, 2007 Catalyst Online is published weekly, updated as needed and improved from time to time by the MUSC Office of Public Relations for the faculty, employees and students of the Medical University of South Carolina. Catalyst Online editor, Kim Draughn, can be reached at 792-4107 or by email, catalyst@musc.edu. Editorial copy can be submitted to Catalyst Online and to The Catalyst in print by fax, 792-6723, or by email to catalyst@musc.edu. To place an ad in The Catalyst hardcopy, call Island Publications at 849-1778, ext. 201.