The Johns Hopkins University-Tufts Trial Innovation Center (TIC)
BIOS and the Johns Hopkins Institute for Clinical and Translational Research (ICTR) have been awarded a seven-year, $25 million grant from the National Institutes of Health’s National Center for Advancing Translational Sciences (NCATS) to form, along with Tufts University School of Medicine, one of three Trial Innovation Centers (TICs).
The goal of the centers is to promote innovations in the efficiency and quality of NIH-funded trials. The centers are part of the NCATS Trial Innovation Network and will work with the national Clinical and Translational Science Program, which funds a consortium of 64 medical research institutions in 31 states and the District of Columbia. The centers will help the institutions form a long-standing infrastructure for multicenter studies to be funded by NIH and other funding agencies.
Daniel F. Hanley, M.D., the Jeffrey and Harriet Legum Professor of Acute Neurological Medicine and director of Brain Injury Outcomes program at the Johns Hopkins University School of Medicine, is the principal investigator for the grant. Daniel Ford, M.D., M.P.H., the David M. Levine Professor and vice dean for clinical investigation at the Johns Hopkins University School of Medicine, is a co-principal investigator, as is Harry P. Selker, executive director of the Institute for Clinical Research and Health Policy Studies and dean of the Clinical and Translational Science Institute at the Tufts University School of Medicine. Karen Lane, an assistant professor of neurology at Johns Hopkins and a co-investigator, will serve as executive director. Megan Kasimatis Singleton, J.D., M.B.E., assistant dean for human research protection and director of the Office of Human Subjects Research at Johns Hopkins, will coordinate Institutional Review Board activities supported by the grant.
Dr. Daniel Hanley
Since 1996, Dr. Hanley has been a Professor of Neurology, Neurosurgery and Anesthesia/Critical Medicine at Johns Hopkins Medical Institutions. Since 1999, Dr. Hanley has also been Professor in the School of Nursing, the Jeffrey and Harriett Legum Professor of Acute Care Neurology and Director of Brain Injury Outcomes Program at Johns Hopkins Medical Institutions. Dr. Hanley is a graduate of Williams College and Cornell University Medical College and has board certification in internal medicine, neurology and psychiatry.
Dr. Hanley is a leading expert on multiple types of brain injury and has received more than 40 clinical and basic research grants, predominately from the National Institutes of Health and the FDA Orphan drugs program. He has published more than 250 articles in peer-reviewed journals, has received the Alexander Humboldt Research Prize for his accomplishments in brain injury research and has extensive clinical trials experience in that field. His trainees are directors of more than 25 brain intensive care units across the United States.
Dr. Hanley is on the board of directors of the National Stroke Association, for which he has developed nationally recognized education and training programs. He has significant experience in the areas of clinical trials design, organization and interpretation of drug and device development, and FDA regulatory compliance. He is the principal investigator for the NIH-sponsored MISTIE and CLEAR trials investigating minimally invasive neurosurgical techniques to treat hemorrhagic stroke. He is the principal investigator for Johns Hopkins-Tufts NCATS Trial Innovation Center, and as such, he leads the collaborative efforts with the National Institute on Aging to advance education and therapeutics in well-designed CTSA clinical trials investigating Alzheimer’s disease and other diseases of aging.
Dr. Daniel Ford
Daniel E. Ford, MD, MPH, is a general internist who has been caring for patients and conducting clinical research for over 20 years. He has worked with patients, nurses, social workers and physicians to develop and test new approaches to improving outcomes for patients, mostly those seen in primary care. He has led randomized clinical trials to improve outcomes in depression, smoking cessation and addictions. He published ground-breaking studies on the relationship between depression and sleep and understanding how depression is a risk factor for developing heart disease. Since 2005 he has been the Vice Dean for Clinical Investigation at The Johns Hopkins School of Medicine and the PI of the Clinical and Translational Science Award Program. In this role he has led the development of using Electronic Medical Records for research and expanding the role for Community Research Advisory Boards.
For the PaTH Research Network Dr. Ford is leading the program at Johns Hopkins. He is also taking the lead in the IRB review of the research and the development of the cohort of patients with atrial fibrillation.
Dr. Harry Selker
Dr. Harry P. Selker is Dean of Tufts Clinical and Translational Science Institute (CTSI) and Executive Director of the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center. As Dean, he provides leadership for programs and infrastructure that support clinical and translational research at the Tufts University schools and affiliated hospitals, and other academic, community-based, and industry CTSI partners. He practices medicine at Tufts Medical Center.
Dr. Selker‘s research focuses on the development of treatment strategies, decision aids, and systems aimed at improving medical care. He is known for his studies of the factors influencing emergency cardiac care and for development of "clinical predictive instruments," mathematical models that are used as decision aids. They provide emergency physicians and paramedics with predictions for their patients’ likely cardiac diagnoses and outcomes for real-time use in clinical care. This has included the conduct of multiple large national clinical effectiveness trials that have demonstrated better treatment and clinical outcomes for patients with acute coronary syndromes. Additionally, Dr. Selker has done research to advance clinical study design, execution, issues around informed consent, data analysis, mathematical predictive modeling of medical outcomes, and comparative effectiveness research.
Dr. Selker has contributed to health services and health policy research, with a focus on translational research that impacts public health. He has provided advice about healthcare delivery and medical research to policymakers, including the House and Senate authors of the Affordable Care Act. Dr. Selker has served as President of the Society of General Internal Medicine, the Society for Clinical and Translational Science, the Association for Clinical Research Training, and the Association for Clinical and Translational Science, and is currently Chairman of the Clinical Research Forum.