Defense Health Program Department of Defense Lung Cancer Research Program: Clinical Translational Research Partnership Award

The FY21 LCRP Clinical Translational Research Partnership Award mechanism supports partnerships between clinicians and research scientists that will accelerate the movement of promising ideas in lung cancer into clinical applications. This award supports the development of translational research collaborations between two independent, faculty-level (or equivalent) investigators to address a critical problem or question in lung cancer in a manner that would be less readily achievable through separate efforts. One partner in the collaboration must be a research scientist and the other must be a clinician. In addition, one partner in the collaboration is strongly encouraged to be an active duty Service member or Federal employee from a Department of Defense (DoD) military treatment facility or laboratory, or a Department of Veterans Affairs (VA) medical center or research laboratory. It should be clear that both have had equal intellectual input into the design of the research project. Multi-institutional partnerships are encouraged but not required. At least one member of the partnership must have experience either in lung cancer research or lung cancer patient care. A proposed project in which the clinical partner merely supplies tissue samples or access to patients will not meet the intent of this award mechanism.

This mechanism is intended to support a pilot, proof-of-principle, or early-phase clinical trial and associated correlative science. 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 interventions on biomedical or behavioral health-related outcomes. It is expected that the proposed trial will have a welldeveloped rationale, strong preliminary data, trial methodology, and execution plan. Any proposed preclinical studies in addition to the trial should be appropriately justified as to its necessity to inform and interpret trial results and the correlative science. If the proposed research would ultimately require U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) submission, applications must demonstrate availability of, and access to, clinical reagents (e.g., therapeutic molecules) and patient population(s).