Request Information RFI) NIH CTSA Neuroscience Research Notice Number: NOT-NS-11-007 Key Dates Release Date: March 18, 2011 Responses Due By: assure consideration, comments must received May 20, 2011 Issued National Institute Neurological Disorders Stroke NINDS) National Center Research Resources NCRR) NIH Blueprint Neuroscience Research
http://neuroscienceblueprint.nih.gov Purpose NIH Clinical Translational Science Award program CTSA) Neuroscience Research Trans-NIH Workgroup seeking public comment potential programs facilitate neuroscience research using existing new research resources. CTSA program supports national consortium medical research institutions committed speeding translation laboratory discoveries treatments patients, engaging communities clinical research efforts, training new generation clinical translational researchers
http://www.ctsaweb.org/). this RFI, neuroscience research defined broadly the conduct basic, clinical, translational research relevant conditions diseases the nervous system. Neuroscience research employ interdisciplinary research teams include neuroscience researchers areas such as, not limited to, addiction, anatomy, behavioral health, biostatistics, economics, engineering, epidemiology, ethics, information systems technology, minority health, mental health, molecular developmental neurobiology, neurogenetics, neuroimaging, physics, substance disorders neuro-related fields clinical medicine. this RFI, neuro-related fields clinical medicine generate neuroscience researchers include, are limited to, anesthesia, behavioral mental health, cardiovascular medicine, cognitive neuroscience, complementary alternative medicine, developmental disorders the nervous system, emergency medicine, geriatrics, internal medicine, military medicine, neurocritical care, neuroendocrinology, neurology, neurooncology, neuroradiology, neurosurgery, occupational environmental health, ophthalmology, otolaryngology, pediatrics/child neurology, physical medicine rehabilitation, psychiatry, sleep medicine, substance disorders. RFI aims gather information critical gaps, challenges, potential strategies close gaps resolve challenges order develop coordinate resources neuroscience research using CTSA infrastructure. Resources research include--but not limited to--team science, clinical trials infrastructure, collaborative networks, education training, biomedical informatics, clinical research units/centers, community engagement research, ethics, evaluation, novel clinical translational methodologies, pilot collaborative translational clinical studies, public-private partnerships, regulatory knowledge support, translational technologies. Background CTSA program complements programs the NIH Institutes works cooperation other NIH activities other relevant trans-NIH activities. goal the institutional Clinical Translational Science Award CTSA) program to transform local, regional national environment clinical translational science, thereby increasing efficiency speed clinical translational research. transformation be achieved creating academic home, can a center, department, institute, comprising faculty programs integrate clinical translational science across multiple departments, schools, clinical research institutes hospitals. CTSA expected include faculty able conduct original research, develop graduate postgraduate training curricula lead programs integrate clinical translational science across multiple departments, schools, clinical research institutes hospitals. more information, please
http://www.ctsaweb.org. Definitions: the purpose this initiative, clinical research comprises studies trials human subjects meeting NIH definition the PHS 398 instructions see:
http://grants.nih.gov/grants/funding/phs398/phs398.pdf). Translational research includes areas translation. is process applying discoveries generated during research the laboratory, in preclinical studies, the development trials studies humans. second area translation concerns research aimed clinical trials other prospective studies, retrospective studies, observational studies, dissemination implementation enhance adoption best practices the community. Cost-effectiveness prevention treatment strategies also an important part translational science. Bidirectional communication work processes integral each these areas translational research. comparative effectiveness research prevention treatment strategies also important part translational science. Information Requested RFI seeks information critical gaps challenges potential approaches resolve in order enhance resources neuroscience research using infrastructure available through CTSA institutional, regional, the national consortium. Ideas both short-term 6 months-1 year) long-term 2-5 years) approaches develop coordinate neuroscience research research resources welcome. Members the scientific community, scientific organizations, healthcare professionals, patient advocates, the public invited respond any, all the following: Challenges Describe critical gaps other challenges neuroscience research the CTSAs might address. Challenges be the level clinical translational research, clinical trials, participant recruitment amp; retention, special populations, team science collaborative networking, infrastructure, workforce resources, information systems technology, methodology, interventions, the execution, implementation, evaluation programs. Potential Solutions Describe you believe be most innovative approaches address challenges. NIH seeking input advice the following items. Please consider commenting any the items are relevant your work and/or research. Challenges: 1. are critical gaps in, other challenges to, advancing neuroscience research through team science your perspective may include or of following: 1) researcher, 2) patients/consumer individual advocacy group, 3) health care provider, 4) type health care professional, 5) administrator, 6) information systems technology worker, 7) health care payer, 8) research funding organization, 9) private organization, 10) regulatory agency? 2. Identify critical gaps other challenges CTSAs address facilitate clinical and/or translational neuroscience research the CTSAs institutional, regional, and/or national consortium level. 3. Aspects neuroscience research you think been impacted the NIHs investment CTSAs. Please consider commenting any the CTSA functions resources devoted education training, biomedical informatics, clinical research units/centers, community engagement research, ethics, evaluation, novel clinical translational methodologies, pilot collaborative translational clinical studies, public-private partnerships, regulatory knowledge support, translational technologies. 3a. have any these functions resources utilized advance neuroscience research? Feel free give particular examples might serve models others. 3b. have any these functions resources contributed the dissemination the outcomes neuroscience research researchers, clinical practice, patients community groups, policymakers? 4. Drivers the decisions researchers, new treatment developers, drug, device diagnostic manufacturers participate multicenter neuroscience clinical trials conducted within CTSA Consortium infrastructure. 5. are critical gaps other challenges constrain neuroscience clinical trials within CTSAs? are unique challenges highly impact participant recruitment retention especially among participants special populations with rare diseases these clinical trials? 6. are barriers conducting assessing outcomes comparative effectiveness research neuroscience the CTSA institutional, regional, and/or national consortium level? 7. your perspective, please describe interactions between CTSAs basic clinical researchers are neuroscientists, clinicians, nurses, allied health professionals, complementary alternative medicine experts, economists, engineers, epidemiologists, informaticians, methodologists, statisticians interests translational neuroscience research addressing: 7a. Communication, partnership, participation research teams related planned / ongoing studies examining development novel treatments diagnostics, rehabilitation, quality life, symptom identification/symptom management, palliative care, end life, behavioral mental health illness such but limited addiction, depression, post-traumatic stress disorders cognitive impairments such but limited mild cognitive impairments MCI), memory impairments resulting but limited brain injury, Alzheimers vascular diseases, autism, pain, mobility impairments resulting but limited arthritis, bone muscular diseases, spinal cord injury, stroke. 7b. Early career mid-career research training needs. 8. Comment the most challenging barriers engaging private sector including for-profit non-for-profit organizations interact the CTSA Consortium. 9. are critical gaps challenges the execution, implementation, evaluation CTSA programs advance neuroscience research? 10. there issues NIH should consider the development team science advance neuroscience research? Potential Solutions: 1. are potential approaches close critical gaps resolve challenges you described under Challenges Section advance neuroscience research through team science your perspective may include or of following: 1) researcher, 2) patients/consumer individual advocacy group, 3) health care provider, 4) type health care professional, 5) administrator, 6) information systems technology, 7) health care payers, 8) research funding organization, 9) private organization, 10) regulatory agency? 2. CTSAs be utilized conduct preclinical studies early phase clinical trials phase 0/phase I/phase II) CNS drug development. Please comment the level target identification developmental methods. 3. CTSAs might effectively contribute basic, clinical, and/or translational neuroscience research the CTSA institutional, regional, and/or national consortium level. 4. the various neuroscience institutes other funding organizations might leverage value productivity their own investments interacting the CTSAs. 5. can CTSAs better conduct assess outcomes comparative effectiveness research neuroscience the CTSA institutional, regional, and/or national consortium level? 6. most effective approaches ensure continued dissemination the outcomes neuroscience research collection review multistakeholder input the CTSA institutional, regional, and/or national consortium level. 7. can infrastructure the CTSAs best leveraged take advantage advances neuroscientific tools such as, not limited to, neuroimaging, neurogenomics, proteomics, metabolomics biomarker development, early phase studies assess proof biologic activity novel treatments? 8. CTSAs more effectively contribute developing sustaining translational neuroscience research education, training, workforce. 9. can infrastructure the CTSAs leveraged advance neuroscience translational discoveries the development evidence-based medicine any the following research areas: a) Autism b) Behavioral health c) Cancer d) Cardiovascular and/or autonomic system e) Cerebrovascular conditions events f) Complementary Alternative Medicine CAM) g) Concussions, Traumatic Brain Injury TBI), and/or Blast Injury h) Genomics i) Implementation science j) Information dissemination k) Mental health l) Minority underserved populations m) Neurocritical care n) Neurodegenerative disorders o) Neurodevelopmental disorders normative brain development p) Neuroimaging q) Neurological disorders Infant, adolescent, adult, and/or elderly r) Neuroplasiticity s) Neuro-related devices, information systems technology, other technologies t) Neuro- related physical medicine rehabilitation u) Neurotherapeutics v) Neuro-related disorders occupational environmental health w) Nursing x) Pain y) Patient centered outcomes comparative effectiveness research CER) z) Peripheral nerve disorders aa) Post Traumatic Stress Disorder PTSD) bb) Sensory impairments disorders cc) Sleep dd) Spinal cord injury SCI) ee) Substance disorders ff) research areas listed 10. can investigators working translational neuroscience relevant infants, children, adolescents, and/or adults, including elderly, CTSA resources infrastructure? 11. CTSAs encourage developmental perspective, across lifespan, ongoing translational neuroscience research, applicable. 12. can infrastructure the CTSAs best leveraged facilitate translation findings basic research behavioral social neuroscience effective interventions pharmacological, behavioral devices improve health? 13. Given recent decline pharmaceutical company funding nervous system research development, can CTSAs re-invigorate neuroscience drug development? 14. what purpose(s) you utilize CTSA Consortium Neuroscience Thematic Special Interest Group support research career development efforts? RESPONSES assure consideration, comments must received May 20, 2011. Individuals, groups, organizations interested commenting how Clinical Translational Science Awards CTSAs) advance neuroscience research, outlined this RFI, submit comments this RFI. Responses this RFI must submitted electronically using wed-based format
http://www.ninds.nih.gov/funding/rfi-nihctsa-neuroscience.htm. Comments be publicly available, including any personally identifiable confidential business information they contain. Trade secrets should be submitted. Inquiries further information contact: Walter Koroshetz:
koroshetzw@mail.nih.gov Rosemarie Filart:
filartr@mail.nih.gov Jerry Doyle:
doylejj@mail.nih.gov Request Information RFI) for planning purposes only is a solicitation applications an obligation the part the United States U.S.) Government provide support any ideas identified response it. Please note the U.S. Government not pay the preparation any information submitted for use that information. Footnotes: the purposes this RFI, definition comparative effectiveness research CER) adhere that adopted the Federal Coordinating Council given
http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf: Comparative effectiveness research the conduct synthesis research comparing benefits harms different interventions strategies prevent, diagnose, treat monitor health conditions real world settings. purpose this research to improve health outcomes developing disseminating evidence-based information patients, clinicians, other decision-makers, responding their expressed needs, which interventions most effective which patients under specific circumstances. provide information, comparative effectiveness research must assess comprehensive array health-related outcomes diverse patient populations subgroups. Defined interventions compared include medications, procedures, medical assistive devices technologies, diagnostic testing, behavioral change, delivery system strategies. research necessitates development, expansion, use a variety data sources methods assess comparative effectiveness actively disseminate results.