DOD Duchenne Muscular Dystrophy, Clinical/Translational Research Award

Description

The FY24 DMDRP CTRA mechanism supports advanced translational research that will accelerate the movement of promising ideas in DMD research into clinical applications. Translational research may be defined as an integration of basic science and clinical observations. However, applicants should not view translational research as a one-way continuum from bench to bedside. The research plan must involve a reciprocal flow of ideas and information between applied and clinical research. As such, applications must include preliminary and/or published data relevant to DMD to support the proposed research project.This mechanism is intended to support established projects that have moved beyond the realm of basic research and proof of concept studies and have the potential to result in a near-term impact in clinical research or the clinic. Research projects investigating therapies that will be efficacious across the life span, including infants, toddlers, and non-ambulatory individuals, are strongly encouraged. Pilot, proof-of-principle clinical trials, and correlative studies to better inform development of drugs, devices, and other interventions are allowed.Early-Career Partnering PI Option: The FY24 DMDRP encourages applications that include meaningful and productive collaborations between investigators. In an effort to promote enhanced research capacity within the DMD field, the FY24 CTRA includes an option for an Early-Career Partnering Principal Investigator (PI). The Partnering PI Option is structured to accommodate two PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The Early-Career PI will be identified as the Partnering PI. Both PIs should contribute significantly to the development and execution of the proposed research project. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission.The FY24 DMDRP CTRA offers two funding levels (refer to Section II.D.5 Funding Restrictions). Only one funding level category may be chosen per application, and the choice of application category is at the discretion of the applicant. The following are generalized descriptions of the scope of the research appropriate for each funding level:Funding Level 1: Funding Level 1 is intended to support smaller, less complex preclinical and/or clinical research. Pilot clinical trials are allowed. The proposal/application’s direct costs budgeted for the entire period of performance should not exceed $650,000.Funding Level 2: Funding Level 2 is intended to support larger, more complex preclinical and/or clinical research. Pilot clinical trials are allowed. The proposal/application’s direct costs budgeted for the entire period of performance should not exceed $1.35M.Additionally, both funding levels will support an Early-Career Partnering PI Option at the same maximum direct costs and periods of performance, respectively.For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Both pilot clinical trials and clinical research are permitted under this mechanism.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.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.All investigators applying to FY24 DMDRP funding opportunities and conducting clinical research are encouraged to consult the Strategies to Promote Diversity in Muscular Dystrophy Research Participation developed by the MDCC.

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