Request for Information (RFI) on NIH CTSA Neuroscience Research

Notice Number: NOT-NS-11-007

Release Date: March 18, 2011
Responses Due By: To assure consideration, comments must be received by May 20, 2011

National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Research Resources (NCRR)
NIH Blueprint for Neuroscience Research http://neuroscienceblueprint.nih.gov

NIH Clinical and Translational Science Award program (CTSA) Neuroscience Research Trans-NIH Workgroup is seeking public comment on potential programs to facilitate neuroscience research using existing or new research resources. The CTSA program supports a national consortium of medical research institutions committed to speeding the translation of laboratory discoveries into treatments for patients, engaging communities in clinical research efforts, and training a new generation of clinical and translational researchers (http://www.ctsaweb.org/). For this RFI, neuroscience research is defined broadly as the conduct of basic, clinical, and translational research relevant to conditions and diseases of the nervous system. Neuroscience research may employ interdisciplinary research teams that include neuroscience researchers from areas such as, but not limited to, addiction, anatomy, behavioral health, biostatistics, economics, engineering, epidemiology, ethics, information systems and technology, minority health, mental health, molecular and developmental neurobiology, neurogenetics, neuroimaging, physics, substance use disorders and neuro-related fields of clinical medicine. For this RFI, the neuro-related fields of clinical medicine which generate neuroscience researchers include, but are not limited to, anesthesia, behavioral and mental health, cardiovascular medicine, cognitive neuroscience, complementary and alternative medicine, developmental disorders of the nervous system, emergency medicine, geriatrics, internal medicine, military medicine, neurocritical care, neuroendocrinology, neurology, neurooncology, neuroradiology, neurosurgery, occupational and environmental health, ophthalmology, otolaryngology, pediatrics/child neurology, physical medicine and rehabilitation, psychiatry, sleep medicine, and substance use disorders.

This RFI aims to gather information on critical gaps, challenges, and potential strategies to close gaps and resolve challenges in order to develop and coordinate resources for neuroscience research using the CTSA infrastructure. Resources for research could include--but are not limited to--team science, clinical trials infrastructure, collaborative networks, 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, public-private partnerships, regulatory knowledge and support, and translational technologies.

Background

The CTSA program complements the programs of the NIH Institutes and works in cooperation with other NIH activities and other relevant trans-NIH activities.

The goal of the institutional Clinical and Translational Science Award (CTSA) program is to transform the local, regional and national environment for clinical and translational science, thereby increasing the efficiency and speed of clinical and translational research. This transformation will be achieved by creating an academic home, which can be a center, department, or institute, comprising faculty and programs that integrate clinical and translational science across multiple departments, schools, clinical and research institutes and hospitals. The CTSA is expected to include faculty able to conduct original research, develop graduate and postgraduate training curricula and lead programs that integrate clinical and translational science across multiple departments, schools, clinical and research institutes and hospitals. For more information, please see http://www.ctsaweb.org.

Definitions: For the purpose of this initiative, clinical research comprises studies and trials in human subjects meeting the NIH definition in the PHS 398 instructions (see: https://grants.nih.gov/grants/funding/phs398/phs398.pdf). Translational research includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. The second area of translation concerns research aimed at clinical trials and other prospective studies, retrospective studies, observational studies, and dissemination and implementation to enhance the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies also is an important part of translational science. Bidirectional communication and work processes are integral to each of these two areas of translational research. The comparative effectiveness research of prevention and treatment strategies is also an important part of translational science.

Information Requested

This RFI 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.
2. The Potential Solutions Describe what you believe to be the most innovative approaches to address these challenges.

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 in, and other challenges to, advancing 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 worker, (7) health care payer, (8) research funding organization, (9) private organization, (10) regulatory agency?

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.

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, public-private partnerships, regulatory knowledge and support, and translational technologies.

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.
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?

4. Drivers for the 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.

5. What are the critical gaps and other challenges that constrain 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?

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?

7. From 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.
7b. Early career and mid-career research training needs.

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.

9. What are the critical gaps and challenges in the execution, implementation, and evaluation of CTSA programs to advance neuroscience research?

10. Are there issues that NIH should consider in the development of team science to advance neuroscience research?

Potential Solutions: 

1. What are the potential approaches to close the critical gaps and resolve other challenges which you described under the 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?

2. How 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.

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.

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.

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?

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.

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?

8. How CTSAs could more effectively contribute to developing and sustaining translational neuroscience research education, training, and workforce.

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) Cerebrovascular conditions and events
f) Complementary and 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 and underserved populations
m) Neurocritical care
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

10. How can investigators working on translational neuroscience relevant to infants, children, adolescents, and/or adults, including the elderly, use CTSA resources and infrastructure?

11. How CTSAs could encourage a developmental perspective, across the lifespan, in ongoing translational neuroscience research, when applicable.

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?

13. Given the recent decline in pharmaceutical company funding for nervous system research and development, how can the CTSAs re-invigorate neuroscience drug development?

14. For what purpose(s) would you utilize a CTSA Consortium Neuroscience Thematic Special Interest Group to support your research and career development efforts?

RESPONSES

To assure consideration, comments must be received by May 20, 2011.

Individuals, groups, and organizations interested in commenting on how the Clinical and Translational Science Awards (CTSAs) can advance neuroscience research, as outlined in this RFI, may submit comments to this RFI. Responses to this RFI must be submitted electronically using the wed-based format at http://www.ninds.nih.gov/funding/rfi-nihctsa-neuroscience.htm. Comments will be made publicly available, including any personally identifiable or confidential business information that they contain. Trade secrets should not be submitted.

For further information contact:

Walter Koroshetz: koroshetzw@mail.nih.gov

Rosemarie Filart: filartr@mail.nih.gov

Jerry Doyle: doylejj@mail.nih.gov

This Request for Information (RFI) is for planning purposes only and is not a solicitation for applications or an obligation on the part of the United States (U.S.) Government to provide support for any ideas identified in response to it. Please note that the U.S. Government will not pay for the preparation of any information submitted or for its use of that information.

Footnotes:

• For the purposes of this RFI, the definition of comparative effectiveness research (CER) will adhere to that adopted by the Federal Coordinating Council given at http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf:
  

Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in real world settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.

• To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations and subgroups.
• Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies.
• This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness and actively disseminate the results.