Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Agency Name: Joshua D McKean Grants Officer

Description:

Maturing research ideas into clinical practice and patient benefit is at the heart of all CDMRP research programs. Despite significant investment, the gap between what is possible and what is achieved remains. Even after information, tools, and interventions have been successfully evaluated in their intended populations, the development of knowledge to support their broader dissemination and implementation has often remained outside the scope of previous clinically focused award mechanisms.

The FY24 MBRP PCRA intends to bridge the gap between research, practice, and policy by building a knowledge base that provides clinically useful findings about how interventions, clinical practices/guidelines, tools, and policies can be deployed to targeted populations at the appropriate time at the point of need. Funding from this award mechanism must support clinical research or clinical trials but cannot be used for preclinical or animal research. Applications may propose prospective or retrospective research involving human subjects, human subject data/records, and human anatomical substances.

The FY24 PCRA may support studies focusing on the following (not all inclusive):

• Research that accelerates the uptake and implementation of evidence-based research into clinical practice

• Comparative effectiveness research comparing the benefits and harms of emerging or established interventions and strategies to prevent, diagnose, treat, and monitor health conditions in “real-world” settings

• Development and evaluation of strategies to overcome barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, tools, policies, and guidelines

• Analysis of existing clinical data or clinical data resources to inform clinical practice

• Modification of established clinical tools for their intended population or environment

• Analysis of existing clinical tools to maximize patient-relevant outcomes

• Identification and analysis of the circumstances that create a need to stop or reduce (“de-implement”) the use of interventions, tools, policies, and guidelines that are ineffective, unproven, low-value, or harmful

• Analysis of burn outcomes associated with the implementation of clinical practice guidelines, evidence-based practices, and process improvements

The following are important aspects of the FY24 MBRP PCRA:

• Precision Medicine Approaches: When appropriate, the MBRP encourages the use of precision medicine approaches. These tailored treatments deliver the right treatment at the right time while considering an individual’s unique characteristics.

• Preliminary data are required: Inclusion of preliminary data relevant to the proposed clinical research/trial is required.

• Study Population: The application should demonstrate the availability of and access to a suitable patient population that will support a meaningful outcome for the study. The application should include a discussion of how accrual goals will be achieved, as well as the strategy for inclusion of women and minorities in the clinical trial appropriate to the objectives of the study. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, gender, ethnicity, or race (typically classified as exempt from Institutional Review Board [IRB] review) are exempt from this requirement.

• Clinical Trial Start Date: If applicable, the proposed clinical trial is expected to begin no later than 6 months after the award date.

• Intervention Availability: If applicable, the application should demonstrate the documented availability of and access to the drug/compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study.

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 (http://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.

Applications involving multidisciplinary collaborations among academia, industry, the military Services, the U.S. Department of Veterans Affairs (VA), and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, and/or their Families. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

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 co-investigator) 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.

Impact: The overall impact of the proposed research is a key component of this award mechanism. High-impact research will, if successful, lead to the clinical implementation of therapeutics, technologies, or clinical practice guidelines that advance the care of burn-injured casualties.

Relevance to Military Health: Relevance to the health care needs of burn-injured military Service Members is a key feature of this award.

Use of DOD or VA Resources: If the proposed research involves access to active-duty military and/or VA patient populations and/or DOD or VA resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Refer to Section II.D.2.b.ii, Full Application Submission Components, for detailed information. Refer to the General Application Instructions, Appendix 1, for additional information.

Applicants are encouraged to integrate and/or align their research projects with DOD and/or VA research laboratories and programs. Collaboration with DOD or VA investigators is also encouraged. A list of websites that may be useful in identifying additional information about ongoing DOD and VA areas of research interest or potential opportunities for collaboration can be found in Appendix 2.

Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All DOD-funded research involving new and ongoing research with human data,

human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRDC Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO), prior to research implementation. This administrative review requirement is in addition to the local IRB or Ethics Committee (EC) review. Local IRB/EC approval at the time of application submission is not required; however, local IRB/EC approval is necessary prior to OHRO review. Allow up to 3 months to complete the OHRO regulatory review and approval process following submission of all required and complete documents to the OHRO. Refer to the General Application Instructions, Appendix 1, and the OHARO web page

https://mrdc.health.mil/index.cfm/collaborate/research_protections for additional information.

If the proposed research involves more than one institution, a written plan for single IRB review arrangements must be provided at the time of application submission or award negotiation. The lead institution responsible for developing the master protocol and master consent form should be identified and should be the single point of contact for regulatory submissions and requirements.

The types of awards made under the program announcement will be assistance agreements. An assistance agreement can take the form of a grant or cooperative agreement. The level of government involvement during the project’s period of performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial government involvement” is anticipated, a grant will be made (31 USC 6304). Conversely, if “substantial government involvement” is anticipated, a cooperative agreement will be made (31 USC 6305). Substantial involvement means that members of the U.S. government will assist, guide, coordinate, or participate in project activities.

The award type, along with the start date, will be determined during the negotiation process.

The anticipated total costs budgeted for the entire period of performance for an FY24 MBRP Patient-Centered Research Award should not exceed $2.2M. 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 $4.4M to fund approximately two Patient-Centered Research Award applications. 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.

Grantor Contact Information: CDMRP Help Desk Phone: 301-682-5507 Email: help@eBRAP.org