DOD Chronic Pain Management, Pain Management Collaborative Clinical Research Award

The intent of the FY23 CPMRP PMCCRA is to support large-scale pragmatic comparative effectiveness and implementation science clinical trials that will facilitate the acceptance and utilization of evidence-based chronic pain management clinical applications, such as health care products, technologies, clinical practice guidelines, and/or models of care. PMCCRA applications should explain how the proposed work will inform the development, refinement, and/or revision of existing standards of care, recommendations, or guidelines for managing chronic pain. Military and Veterans health care systems and other health care entities that provide services to Service Members, Veterans, and their families are the targeted organizations for this program. Research conducted in partnership with eligible VA and Military Health System (MHS) providers is essential for obtaining meaningful and relevant research results in “real world” health care delivery systems serving Veterans, Service Members, and their beneficiaries. Applications to the FY23 CPMRP PMCCRA are aligned with appropriations specifically intended for chronic pain research, therefore, all applications to the funding opportunity must address chronic pain either alone or in the context of common comorbidities. Applications primarily focused on comorbid conditions (e.g., TBI, depression, posttraumatic stress disorder [PTSD]) are not appropriate for the FY23 CPMRP PMCCRA. Studies seeking to advance new and novel opioid-based therapeutic interventions do not meet the intent of this

DOD FY23 Chronic Pain Management award mechanism and will not be selected for funding. Studies seeking to understand and reduce opioid utilization in chronic pain management within the context of current prescribing practices are acceptable.

Funding from this award mechanism must support a clinical trial. A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. For more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/Human%20Subjects%20Resource%20Document.pdf.

Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.

The FY23 CPMRP PMCCRA mechanism supports implementation science and/or comparative effectiveness research. Clinical trials under these Focus Areas should be restricted to pain management interventions that have already been shown to be efficacious in some clinical settings. Studies seeking to evaluate new therapies or approaches, either pharmacological or non-pharmacological, do not meet the intent of the award mechanism. Applicants seeking funding for a clinical trial of novel treatments or untested approaches to chronic pain management are encouraged to consider the FY23 Clinical Exploration Award.

The FY23 CPMRP PMCCRA is designed to be a phased award comprised of a 15-month planning phase award performance period intended for the completion of activities required to initiate the planned clinical trial (e.g., obtaining regulatory approvals, finalizing of collection tools and common data elements (CDEs), study site onboarding and activation). Execution of the full-scale clinical trial will be considered an optional second phase research effort.