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Congressionally Directed Medical Research Programs (CDMRP) -- 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).
Consumer advocate involvement in the application is strongly encouraged. As part of the research team, the consumer advocate would assist in the development of the research question, project design, oversight, recruitment, and evaluation, as well as other significant aspects of the proposed project. As a lay representative, the consumer advocate should be an individual who has been diagnosed with lung cancer and is active in a lung cancer advocacy organization. The consumer advocate role should be focused on providing objective input on the research and its potential impact for individuals with, or at risk for, lung cancer.
The success of the project must be supported by the unique skills and contributions of each partner. The proposed study must include clearly stated plans for interactions between the Principal Investigators (PIs) and institutions involved. The plans must include communication, coordination of research progress and results, and data transfer. Additionally, multi-institutional applications must provide an intellectual property plan to resolve potential intellectual and material property issues and to remove institutional barriers that might interfere with achieving high levels of cooperation to ensure the successful completion of this award.
• Required Pre-Application Deadline: July 14, 2021
• Application Submission Deadline: July 28, 2021
Areas of Interest
To be considered for funding, applications for the FY21 LCRP Clinical Translational Research Partnership Award must address at least one of the following Areas of Emphasis listed below: • Identify innovative strategies for prevention of the occurrence of lung cancer. • Identify innovative strategies for the screening and early detection of lung cancer. • Understand the molecular mechanisms of initiation and progression to lung cancer. • Understand contributors to lung cancer development other than tobacco. • Identify innovative strategies for the treatment of lung cancer. • Identify innovative strategies for the prevention of recurrence of or metastases from lung cancer. • Develop or optimize prognostic or predictive markers to assist with therapeutic decisionmaking. • Understand mechanisms of resistance to treatment (primary and secondary). • Identify innovative strategies for lung cancer care delivery (clinical management/ surveillance/symptom management). • Understand factors that contribute to the health disparities in lung cancer, such as biological contributors; environmental, social, and cultural factors; and access to health care.
• PIs must be at or above the level of Assistant Professor (or equivalent).
• The clinician must be an M.D., M.D./Ph.D., or equivalent with clinical duties and/or responsibilities.
An eligible PI, regardless of ethnicity, nationality, or citizenship status, must be employed by, or affiliated with, an eligible organization.
The anticipated direct costs budgeted for the entire period of performance for an FY21 LCRP Clinical Translational Research Partnership Award will not exceed $1.2M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.