Request for Information (RFI) on the NIH CTSA Neuroscience Research

This RFI (NOT-NS-11-007) seeks information on critical gaps and challenges and potential approaches to resolve them in order to enhance resources for neuroscience research using infrastructure available through CTSA institutional, regional, and the national consortium. Ideas for both short-term (6 months-1 year) and long-term (2-5 years) approaches to develop and coordinate neuroscience research and research resources are welcome. Members of the scientific community, scientific organizations, healthcare professionals, patient advocates, and the public are invited to respond to any, or all of the following:

1. The Challenges - Describe the critical gaps and other challenges in neuroscience research that the CTSAs might address. Challenges can be at the level of clinical and translational research, clinical trials, participant recruitment & retention, special populations, team science and collaborative networking, infrastructure, workforce resources, information systems and technology, methodology, interventions, and the execution, implementation, and evaluation of programs.
   
   
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2. The Potential Solutions - Describe what you believe to be the most innovative approaches to address these challenges.
   
   
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The NIH is seeking input and advice on the following items. Please consider commenting on any of the items that are relevant to your work and/or research.

Challenges:

1. What are the critical gaps and other challenges to advance neuroscience research through team science from your perspective which may include one ore more of the following: (1) researcher, (2) patients/consumer individual or advocacy group, (3) health care provider, (4) other type of health care professional, (5) administrator, (6) information systems and technology worker, (7) health care payer, (8) research funding organization, (9) private organization, (10) regulatory agency, (11) legal entity, or (12) policy maker?
   
   
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2. Identify critical gaps and other challenges CTSAs could address to facilitate clinical and/or translational neuroscience research at the CTSAs’ institutional, regional, and/or national consortium level.
   
   
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3. Aspects of neuroscience research which you think have been impacted by the NIH’s investment in CTSAs. Please consider commenting on any of the CTSA functions and resources devoted to education and training, biomedical informatics, clinical research units/centers, community engagement and research, ethics, evaluation, novel clinical and translational methodologies, pilot and collaborative translational and clinical studies, private- public partnerships, regulatory knowledge and support, and translational technologies.
   
   
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   3a. How have any of these functions and resources been utilized to advance neuroscience research? Feel free to give particular examples that might serve as models for others.
   
   
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   3b. How have any of these functions and resources contributed to the dissemination of the outcomes of neuroscience research to researchers, clinical practice, patients and community groups, and policymakers?
   
   
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4. Drivers for decisions of researchers, new treatment developers, and drug, device or diagnostic manufacturers to participate in multicenter neuroscience clinical trials conducted within the CTSA Consortium infrastructure.
   
   
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5. What are the critical gaps and other challenges in developing and conducting these neuroscience clinical trials within the CTSAs? What are the unique challenges that highly impact participant recruitment and retention especially among participants of special populations and with rare diseases in these clinical trials?
   
   
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6. What are the barriers to conducting and assessing outcomes in comparative effectiveness research in neuroscience at the CTSA institutional, regional, and/or national consortium level?
   
   
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7. For your perspective, please describe interactions between the CTSAs and basic or clinical researchers who are neuroscientists, clinicians, nurses, allied health professionals, complementary and alternative medicine experts, economists, engineers, epidemiologists, informaticians, methodologists, or statisticians with interests in translational neuroscience research in addressing:
   

   7a. Communication, partnership, or participation in research teams related to planned and / or ongoing studies examining the development of novel treatments or diagnostics, rehabilitation, quality of life, symptom identification/symptom management, palliative care, end of life, behavioral and mental health and illness such as but not limited to addiction, depression, and post-traumatic stress disorders cognitive impairments such as but not limited to mild cognitive impairments (MCI),memory impairments resulting from but not limited to brain injury, Alzheimer’s and vascular diseases, autism, pain, or mobility impairments resulting from but not limited to arthritis, bone or muscular diseases, spinal cord injury, and stroke.
   
   
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   7b. Early career and mid-career research training needs?
   
   
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8. Comment on the most challenging barriers to engaging the private sector including for-profit and non-for-profit organizations to interact with the CTSA Consortium.
   
   
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9. What are the critical gaps and challenges in the execution, implementation, and evaluation of CTSA programs to advance neuroscience research?
   
   
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10. Are there issues that NIH should consider in the development of team science to advance neuroscience research?
    
    
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Potential Solutions:

1. What are the potential approaches to close the critical gaps and resolve other challenges which you described under “Challenges Section” to advance neuroscience research through team science from your perspective which may include one or more of the following: (1) researcher, (2) patients/consumer individual or advocacy group, (3) health care provider, (4) other type of health care professional, (5) administrator, (6) information systems and technology, (7) health care payers, (8) research funding organization, (9) private organization, (10) regulatory agency, (11) legal entity, or (12) policy maker?
   
   
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2. How the CTSAs could be utilized to conduct preclinical studies and early phase clinical trials (phase 0/phase I/phase II) for CNS drug development? Please comment at the level of target identification and developmental methods.
   
   
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3. How CTSAs might more effectively contribute to basic, clinical, and/or translational neuroscience research at the CTSA institutional, regional, and/or national consortium level.
   
   
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4. How the various neuroscience institutes and other funding organizations might leverage the value and productivity of their own investments by interacting with the CTSAs.
   
   
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5. How can the CTSAs better conduct and assess outcomes in comparative effectiveness research in neuroscience at the CTSA institutional, regional, and/or national consortium level?
   
   
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6. The most effective approaches to ensure continued dissemination of the outcomes of neuroscience research and collection and review of multistakeholder input at the CTSA institutional, regional, and/or national consortium level.
   
   
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7. How can the infrastructure of the CTSAs best be leveraged to take advantage of advances in neuroscientific tools such as, but not limited to, neuroimaging, neurogenomics, proteomics, metabolomics and biomarker development, for early phase studies to assess proof of biologic activity of novel treatments?
   
   
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8. How CTSAs could more effectively contribute to developing and sustaining translational neuroscience research education, training, and workforce.
   
   
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9. How can the infrastructure of the CTSAs be leveraged to advance neuroscience translational discoveries into the development of evidence-based medicine in any of the following research areas:
   
   
   a) Autism
   b) Behavioral health
   c) Cancer
   d) Cardiovascular and/or autonomic system
   e) Neurocritical care
   f) Cerebrovascular conditions and events
   g) Complementary and Alternative Medicine (CAM)
   h) Concussions, Traumatic Brain Injury (TBI), and/or Blast Injury
   i) Genomics
   j) Implementation science
   k) Information dissemination
   l) Mental health
   m) Minority and underserved populations
   n) Neurodegenerative disorders
   o) Neurodevelopmental disorders and normative brain development
   p) Neuroimaging
   q) Neurological disorders of Infant, adolescent, adult, and/or elderly
   r) Neuroplasiticity
   s) Neuro-related devices, information systems and technology, and other technologies
   t) Neuro- related physical medicine and rehabilitation
   u) Neurotherapeutics
   v) Neuro-related disorders in occupational and environmental health
   w) Nursing
   x) Pain
   y) Patient centered outcomes and comparative effectiveness research (CER)
   z) Peripheral nerve disorders
   aa) Post Traumatic Stress Disorder (PTSD)
   bb) Sensory impairments and disorders
   cc) Sleep
   dd) Spinal cord injury (SCI)
   ee) Substance use disorders
   ff) Other research areas not listed
   
   
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10. How can investigators working on translational neuroscience relevant to infants, children, adolescents, and/or adults, including the elderly, use CTSA resources and infrastructure?
    
    
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11. How CTSAs could encourage a developmental perspective, across the lifespan, in ongoing translational neuroscience research, when applicable.
    
    
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12. How can the infrastructure of the CTSAs best be leveraged to facilitate the translation of findings from basic research in behavioral and social neuroscience into effective interventions – pharmacological, behavioral or devices – to improve health?
    
    
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13. Given the recent decline in pharmaceutical company funding for nervous system research and development, how can the CTSAs re-invigorate neuroscience drug development?
    
    
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14. For what purpose(s) would you utilize a CTSA Consortium Neuroscience Thematic Special Interest Group to support your professional efforts?
    
    
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Additional Comments and Optional Information