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The SCIRP CTA supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of SCI. Applications should articulate both the short- and long-term impact of the proposed research on individuals with SCI and/or their care partners. The proposed intervention(s) to be tested should offer significant potential impact for individuals affected by SCI within the context of one or more of the FY23 SCIRP Focus Areas.Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first in human, phase 0), to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant populations. Alternative trial designs to traditional randomized clinical trials are allowed but should be appropriate to the objective of the trial. Utilization of decentralized clinical trial strategies that leverage virtual elements/tools for participant enrollment, communication, and data collection is especially encouraged.The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public. To help elucidate the realities of treating and managing SCIs while deployed, a resource document is now available on the CDMRP website that outlines Spinal Cord Injury Management Within the Military Health System (MHS). Applicants are encouraged to read and consider this document before preparing their applications. The resource can be accessed at https://cdmrp.health.mil/scirp/pdfs/ Beginner's%20Guide%20to%20Military%20Health%20System.pdf.Employing community collaborations to optimize research impact is required. Research funded by the FY23 SCIRP CTA should be responsive to the needs of people with SCI, their families, and/or their care partners. Research teams are therefore required to establish and utilize effective and equitable collaborations and partnerships with community members to maximize the translational and impact potential of the proposed research. Applications to the FY23 SCIRP CTA are expected to name at least two community partners (e.g., SCI Lived Experience Consultants, representatives of community-based organizations) who will provide advice and consultation throughout the planning and implementation of the research project (see Attachment 4, Collaborative Research Plan).Collaborative research approaches, such as community-based participatory research, participatory action research, and integrated knowledge transition, create partnerships between scientific researchers and community members to create knowledge useable by both sets of stakeholders. Recognizing the strengths of each partner, scientific researchers and community members collaborate and contribute equitably on all aspects of the project, which may include needs assessment, planning, research intervention design, implementation, evaluation, and dissemination. Collaborative research approaches feature shared responsibility and ownership for the research project to ensure non-tokenistic involvement of community members within the research team. Research results are jointly interpreted, disseminated, fed back to affected communities, and may be translated into interventions or policy. These methods are critically important for community-level interventions and can also have important impacts on translational research and prototype development to identify and augment the potential impact of a research program on people living with SCI, their families, and/or their care partners.Collaborative relationships with the lived experience community are often established through integrating community members into research teams as co-researchers, advisors, and/or consultants. Some examples for implementing collaborative research approaches include:• Lived Experience Consultation: The research team includes at least one project advisor with lived SCI experience who will provide advice and consultation throughout the planning and implementation of the research project. Lived Experience Consultants may include individuals with SCI, their family members, and/or their care partners.• Partnership with a Community-Based Organization: The research team establishes partnerships with at least one community-based organization that provides advice and consultation throughout the planning and implementation of the research project. Community-based organizations may include advocacy groups, service providers, policymakers, or other formal organizational stakeholders.• Community Advisory Board Utilization: A community advisory board is composed of multiple community stakeholders and can take many forms, from a board of Lived Experience Consultants to a coalition of community-based organizations or any combination thereof. As with Lived Experience Consultants and organizational partners, the community advisory board provides advice and consultation throughout planning and implementation of the research project.

The SCIRP TRA is intended to support translational research that will accelerate the movement of promising ideas in SCI research into clinical applications. Although not all-inclusive, some examples include demonstration studies of pharmaceuticals and medical devices in preclinical systems and/or clinical research on therapeutics, devices, or practice using human tissues or resources.The ultimate goal of translational research is to move an observation forward into clinical application and accelerate the clinical introduction of health care products, technologies, or practice guidelines. Observations that drive a research idea may be derived from a laboratory discovery, population-based studies, or a clinician’s first-hand knowledge of patients and anecdotal data. However, applicants should not view translational research as a one-way continuum from bench to bedside. The research plan is encouraged to involve a reciprocal flow of ideas and information between basic and clinical science.Applicants need to clearly articulate three points along the translational research spectrum:• Where the field is now;• Where the field will be after the successful completion of the proposed research project; and• What the next step will be after completion of the proposed project.Applications must include preliminary and/or published data that are relevant to SCI and supports the proposed research project.Applications to the FY23 SCIRP TRA may include preclinical animal studies (except where otherwise specified) and/or clinical research involving human subjects and human anatomical substances. Proposal of animal studies is not a required element of this mechanism though applications including animal studies must include a clear justification for the animal model chosen including relevance to human SCI. The FY23 SCIRP TRA may also support ancillary studies that are associated with an ongoing or completed clinical trial and projects that optimize the design of future clinical trials.The FY23 SCIRP TRA also allows funding for a pilot clinical trial as PART of the funded research project where limited clinical testing of a novel intervention or device is necessary to inform the next step in the continuum of translational research. Such pilot clinical trial studies should be small, make up only a portion of the proposed Statement of Work (SOW), and be utilized to establish feasibility of a potential approach or to aid in device or intervention refinement. Alternative trial designs to traditional randomized clinical trials are allowed but should be appropriate to the objective of the trial. If a pilot clinical trial is proposed, utilization of decentralized clinical trial strategies that leverage virtual elements/tools for participant enrollment, communication, and data collection is especially encouraged. Applications that include a pilot clinical trial as part of the proposed research will have additional submission requirements and review criteria. Applications that consist entirely of a clinical trial or multiple pilot clinical trials may be administratively withdrawn.

The SCIRP CTRA is intended to support high-impact and/or new/emerging clinical research that may not be ready for a larger-scale clinical trial and for which feasibility/pilot studies are necessary. Projects should demonstrate potential to impact the standard of care, both immediate and long term, or contribute to evidence-based guidelines for the evaluation and care of military Service Members, Veterans, and other individuals living with SCI.• One goal of the FY23 SCIRP CTRA is to translate current and emerging techniques and interventions into the clinical space to de-risk and inform the design of more advanced trials.• Another goal is to identify the most effective diagnosis, treatment, and rehabilitation options available to support critical decision-making for patients, clinicians, care partners, and policymakers.The application should clearly articulate the scientific and strategic steps and/or preparations the research team will take during AND after the project’s period of performance to advance the research to the next stage of clinical development/implementation.The proposed studies may be interventional or observational and may involve some retrospective data analysis. Note that purely retrospective or database-related research will not be supported under this funding opportunity, some element of prospective human enrollment should be included in the project. Small/pilot clinical trials with human subjects are allowable. Alternative trial designs to traditional randomized clinical trials are allowed but should be appropriate to the objective of the trial. If a clinical trial is proposed, utilization of decentralized clinical trial strategies that leverage virtual elements/tools for participant enrollment, communication, and data collection is especially encouraged.The FY23 SCIRP CTRA differs from the FY23 SCIRP Clinical Trial Award (Funding Opportunity Number HT9425-23-SCIRP-CTA) in that the CTRA allows for the execution of both clinical research projects and clinical trials, whereas the Clinical Trial Award is restricted to the execution of clinical trials only.The FY23 CTRA differs from the FY23 SCIRP Translational Research Award (Funding Opportunity Number HT9425-23-SCIRP-TRA) in that the study proposed within an application to the FY23 SCIRP CTRA may consist entirely of a clinical trial. In contrast, if a clinical trial is proposed within a Translational Research Award application, it must make up only a portion of the project’s Statement of Work.Applications to the FY23 SCIRP CTRA mechanism must support prospective clinical research or clinical trials and may not be used for animal research. Investigators seeking support to conduct studies involving animal research should consider applying to the FY23 SCIRP Translational Research Award mechanism (Funding Opportunity Number HT9425-23-SCIRP-TRA) or FY23 SCIRP Investigator-Initiated Research Award mechanism (Funding Opportunity Number HT9425-23-SCIRP-IIRA).

The SCIRP IIRA is intended to support studies that have the potential to make an important contribution to SCI research, patient care, and/or quality of life.Important aspects of this award mechanism include:• Impact: Applications should articulate the short- and long-term impact of the proposed research on both the SCI research field as well as the SCI community. Projects must address one or more of the FY23 SCIRP Focus Areas.• Relevance to Military Health: Projects should be relevant to spinal cord-injured military Service Members, Veterans, and/or their family members and care partners. Collaboration with military and VA researchers and clinicians is encouraged.• Preliminary Data: Observations that drive a research idea may be derived from laboratory discovery, population-based studies, a clinician’s first-hand knowledge of patients, or anecdotal data. Applications must include preliminary and/or published data that are relevant to the mission of the SCIRP and support the proposed research project.IIRA applications may focus on any phase of research from basic through translational, though studies focused exclusively on target identification are discouraged. Permitted research includes preclinical studies in animal models (except where otherwise specified), research with human subjects or human anatomical substances, as well as ancillary studies associated with an existing clinical trial.Clinical trials are not allowed under this funding opportunity. Applications including animal studies must have a clear justification for the animal model chosen, including relevance to human SCI.

The FY23 PRARP TRA is intended to support studies that will make transformative and advanced contributions to reduce risk of or prevent the development of AD/ADRD. Risk reduction considering TBI and/or military service is of particular interest to the program. The work should significantly accelerate efforts in AD/ADRD research and demonstrate significant positive impact toward improving patient care and/or quality of life.Key elements of this award mechanism include:• Research should be robust: The FY23 PRARP TRA mechanism is geared toward supporting robust, well designed research projects that provide significant, near-term impact on the AD/ADRD field, persons living with dementia, and their families, care-partners/caregivers, and communities. To ensure near-term applicability, inclusion of collaborative community partner approaches is strongly encouraged for all projects and is required for all projects involving clinical research.• Non-incremental advancement: Research projects should leverage existing knowledge to accelerate ideas, strengthen evidence, and move the field forward toward nearer-term impact. Projects proposing incremental advances that do not significantly propel the field are not appropriate for this mechanism.• Feedback to the community: Results and outcomes of the research supported by this mechanism must be relayed back to the community to allow for continued knowledge building.Inclusion of preliminary data is required. Use of animal models must be fully justified for relevance to human health. Clinical research applications are required to include a community collaboration research element.

The TDA is intended to improve diagnosis now. Proposed projects must build knowledge, capacity, and research to reduce important barriers to obtaining a diagnosis, meaningful disease monitoring, and accurate prognosis. Barriers could include but are not limited to cost, patient access and education, clinical implementation, relationship to clinical outcome measures, biomarker validation, diagnosis technologies, lack of longitudinal data to inform prediction/prognosis, health equity barriers including structural and social determinants of health, and more. The investigator must clearly attune their project to provide true benefit to the intended end user – the person with dementia and their families.Key elements of this mechanism are:• Near term applicability: To meet the intent of this mechanism, applications should be focused on addressing diagnosis now. Near term, for the FY23 PRARP TDA, means acceleration within three to five years, focusing on implementation to the community as soon as possible.• Person-focused research: For diagnostic/prognostic outcomes proposed by the research to be successful, those impacted by AD/ADRD need to buy into the approach. This means researchers should design their projects to focus on the people who need the outcomes most, and the best way to do this is to partner with those stakeholders. Therefore, the FY23 PRARP TDA requires all projects to include collaborative community partner approaches.For this mechanism, there is an expectation that the investigator will host a community meeting with a facilitated discussion, to occur within the first three quarters of the period of performance that will help inform the execution of the research. This meeting should involve the intended research population and their community. The intent of this meeting is to gather feedback and input that will inform the execution of the research, optimize and refine research questions and execution therefore as well as help inform the dissemination strategy of the research outcomes.• Prospective recruitment of study participants: To meet the intent of the mechanism, the TDA requires an element of prospective human subjects’ data collection. The proposed project should leverage existing resources where possible; however, the study must ensure the advances proposed by the project aims are representative and applicable to a diverse population. Consideration of equitable, diverse inclusion of the study populations and team is essential to ensuring AD/ADRD diagnostic or prognostic solutions are of benefit to all and is a high priority for the program.

The intent of the FY23 TCA is to support research that focuses on the realities of everyday living for the individual with AD/ADRD, their care partner/caregiver, and/or both, as well as the reaching impact on families and communities. For the purposes of this funding mechanism, “care” does not include medical care (such as medical interventions administered by a physician), as the care landscape extends beyond that of medical interventions to be inclusive of research into integration, education, and support.Key elements of this mechanism are:Person-centered research: All applications to the FY23 PRARP TCA should be person-centered. This mechanism is intended to provide answers and solutions in critical areas to improve quality of life, reduce burden and stress, and increase support for care partners. The research should have near-immediate impact on the intended beneficiaries. To facilitate success, the TCA requires community collaboration for all projects.Focus on outcomes: The intent of the TCA is to advance knowledge and capacity in the AD/ADRD care field. As such, applicants should clearly articulate outcomes, clearly demonstrate a pathway of feasibility and identify realistic approaches to scaling and community level implementation for widespread use. Additionally, applications should plan for and describe how the research will be manualized and fed back into the to the research, lived experience, and care communities. A milestone meeting will be requiredProjects supported by this mechanism must represent a non-incremental advance in the care field. Preliminary data are required. For this mechanism, studies utilizing animal models are not allowed.

The OCRP established an Ovarian Cancer Academy (OCA) in 2009. The OCA is a unique, interactive virtual academy that provides intensive mentoring, national networking, collaborations, and a peer group for junior faculty. The overarching goal of the OCA was to develop successful, highly productive ovarian cancer researchers in a collaborative research and career development environment.In FY23, OCRP is initiating a new academy, the Ovarian Cancer Clinical Trial Academy (OCCTA), which will focus on clinical trial research in ovarian cancer. The intention of the OCCTA is to enhance knowledge within next generation of early career investigators in clinical trial research and to produce effective treatments and cures for ovarian cancer. The OCCTA will bring together established investigators (the Academy Dean and Assistant Dean), established Career Guides (mentors), and a group of Early Career Investigators (ECIs)/Scholars to conduct successful, highly productive clinical trials in ovarian cancer.

The CTRA supports studies that will move promising, well-founded preclinical and/or clinical research findings closer to clinical application, including diagnosis, prognosis, or treatment of TSC. Projects supported by this award mechanism may include, but are not limited to:· Studies moving from preclinical to clinical research and/or the reverse, or analyzing human anatomical substances and/or data associated with completed clinical trials to understand the mechanism of action, or improve diagnosis, prognosis, or treatment. · Studies advancing clinical trial readiness through development of biomarkers, clinical endpoints, and validation of pharmacokinetics/pharmacodynamics. · Pilot clinical trials where limited clinical testing (e.g., small sample size) of a novel intervention to produce information on diagnostic or therapeutic effectiveness, safety, tolerability, or mechanisms of action. These studies should be aimed at obtaining preliminary data leading to the development of interventions with the potential to improve TSC outcomes.Preclinical studies may be appropriate but must include a clinical component. Projects that are strictly animal research will not be considered for funding and should consider other FY23 TSCRP funding opportunities.

The EHDA supports the initial exploration of innovative, high-risk, high-gain, and potentially groundbreaking concepts in the TSC research field. The studies supported by this award mechanism are expected to generate preliminary data for future avenues of scientific investigation. The proposed research project should include a well-formulated, testable hypothesis based on a strong scientific rationale and study design. Applications should demonstrate the ability to achieve interpretable results in the absence of preliminary data supporting the hypothesis. The following are important aspects of the EHDA: · Innovation: Innovative research may introduce a new paradigm, challenge existing paradigms, examine existing problems from new perspectives, or exhibit other highly creative qualities. Research that is an incremental advance upon published data is not considered innovative and is not consistent with the intent of the award mechanism. Although not all-inclusive, the following examples are ways in which the proposed research project may be innovative: ○ Explores a novel idea and/or research question in TSC research and/or patient care. ○ Uses or develops novel methods or technologies to address a question in TSC research and/or patient care. ○ Applies or adapts existing methods or technologies for novel TSC research or clinical purposes that differ fundamentally from those originally intended.