DoD Arthritis Research, Clinical Research Award

The FY24 ATRP CRA is intended to support clinical research that evaluates disease-specific factors and interventions. Research supported by this mechanism is intended to generate clinically useful evidence with potential to optimize patient outcomes and inform clinical care or policy. Research addressing all types of arthritis is encouraged including but not limited to osteoarthritis, post-traumatic arthritis, inflammatory arthritis, juvenile arthritis, or rheumatoid arthritis. The ATRP encourages applications that address sex as a biological variable and understudied arthritis types. The ATRP also encourages applicants to consider whether large data sets or existing studies/consortia can be leveraged to maximize the potential impact of the proposed research.Applicants must address how the proposed research will impact patient care and reduce the burden of disease. It is expected that any research findings would benefit Service Members, Veterans, their Families, and the general public. To meet the intent of the award mechanism, applications must specifically address at least one FY24 ATRP CRA focus area, listed in Section II.A.1, above.Important aspects of this award mechanism include: Impact: The application should explicitly state how outcomes of the proposed research will have a significant impact on arthritis disease management, patient care, and quality of life. Military Relevance: The application should clearly describe how the research addresses the impact of arthritis in the military, which may include its effect on Service Member recruitment, retention, and recovery. Applicants may also choose to include impacts to the Military Health System, which provides health care support to Service Members and their Families (Eligibility TRICARE). Post-Award Transition Plan: The application should include the plan by which knowledge gained after successful completion of the award will be implemented in guidelines, communicated to relevant stakeholders, or move to the next phase of development. Clinical Trial (CT) Option: The FY24 ATRP CRA offers a clinical trial option that provides support to accommodate the costs of a clinical trial. Applications proposing only a clinical trial or proposing clinical research that includes a clinical trial within the period of performance may select the Clinical Trial Option. A description of the standard of care and justification of any control groups must be included in the application.Preliminary data are required: Applications to the FY24 ATRP CRA must include preliminary and/or published data to support the proposed research project. Applicants must demonstrate logical reasoning for the proposed work. To be competitive, the application must include a sound scientific rationale and a well-formulated, testable hypothesis established through a critical review and analysis of the literature.Advancing Womens Health Research and Innovation: The CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological variable. Such research should relate anticipated project findings to improvements in womens health outcomes and/or advancing knowledge for women's health. The ATRP therefore encourages research that addresses how arthritis and arthritis care may affect women uniquely, disproportionately, or differently from men.Rigor of Experimental Design: All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research. The standards are described in SC Landis et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature 490:187-191 (https://www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies. The FY24 ATRP CRA mechanism is intended to support clinical research or clinical trials and may not be used for preclinical or animal research. Applicants seeking funding for preclinical research or animal research should consider the FY24 ATRP Focused Research Award mechanism (Funding Opportunity Number: HT9425FY24ATRFRA).A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research encompasses research with human data, human specimens, and/or interaction with human subjects. Clinical research is observational in nature and includes:(1) Research conducted with human subjects and/or material of human origin such as data, specimens, and cognitive phenomena for which an investigator (or coinvestigator) does not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention. Research meeting this definition may include but is not limited to: (a) mechanisms of human disease, (b) diagnostic or detection studies (e.g., biomarker or imaging), (c) health disparity studies, and (d) development of new technologies.(2) Epidemiologic and behavioral studies that do not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention.(3) Outcomes research and health services research that do not fit under the definition of clinical trial.Excluded from the definition of clinical research are in vitro studies that utilize human data or specimens that cannot be linked to a living individual and meet the requirements for exemption under 46.104(d)(4) of the Common Rule.The funding instrument for awards made under the program announcement will be grants (31 USC 6304).The anticipated total costs budgeted for the entire period of performance for an FY24 ATRP CRA should not exceed $1.5M or $3.0M (Clinical Trial Option). Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards supported with FY24 funds will be made no later than September 30, 2025.The CDMRP expects to allot approximately $6.0M to fund approximately two Clinical Research Award applications and one Clinical Research Award Clinical Trial Option application. Funding of applications received is contingent upon the availability of federal funds for this program, the number of applications received, the quality and merit of the applications as evaluated by peer and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY24 funding opportunity will be funded with FY24 funds, which will expire for use on September 30, 2030.