DoD Lung Cancer, Translational Research Partnership Award by Department of Defense

The FY18 LCRP 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 central 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.

Observations that drive a research idea may be derived from a laboratory discovery, population- based studies, or a clinician’s firsthand knowledge of patients and anecdotal data. The ultimate goal of translational research is to move a concept or observation forward into clinical application. However, members of the partnership 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 basic and clinical science.

This mechanism is intended to fund a broad range of translational studies, including, but not limited to, the following:

• Studies advancing/translating in vitro and/or animal studies to applications with human samples/cohorts.
• Late-stage preclinical work leading to/preparing for a clinical trial, e.g., Investigational New Drug (IND) application submission.
• Pilot, proof-of-principle clinical trials (must include documentation of an existing IND or Investigational Device Exemption (IDE), if applicable).
• Correlative studies that are associated with an open/ongoing or completed clinical trial and projects that develop endpoints for clinical trials.

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.

Preliminary data to support the feasibility of the research hypotheses and research approaches are required; however, these data do not necessarily need to be derived from studies of lung cancer. Clinical trials are supported by this award mechanism and, if proposed, require the submission of Attachment 8, Human Subject Recruitment and Safety Procedures.

Military Relevance: The LCRP seeks to support research that is relevant to the healthcare needs of military Service members, Veterans, and their families. Military relevance will be considered in determining relevance to the mission of the DHP and FY18 LCRP during programmatic review. Investigators are strongly encouraged to consider the following characteristics as examples of how a project may demonstrate military relevance:

• Use of military or VA patient populations, biospecimens, data/databases, or programs in the proposed research.
• Collaboration with DoD or VA investigators.
• Involvement of military consultants (Army, Air Force) or specialty leaders (Navy, Marine Corps) to the Surgeons General in a relevant specialty area.
• Description of how the knowledge, information, products, or technologies gained from the proposed research could be implemented in a dual-use capacity to address a military need that also benefits the civilian population.
• Explanation of how the project addresses an aspect of lung cancer that has direct relevance to military Service members, Veterans, or other Military Health System beneficiaries, including environmental exposures other than tobacco.

The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public.

The anticipated direct costs budgeted for the entire period of performance for an FY18 LCRP Translational Research Partnership Award will not exceed $900,000. Refer to Section II.D.5,Funding Restrictions, for detailed funding information.

The FY18 LCRP 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 central 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.

Observations that drive a research idea may be derived from a laboratory discovery, population- based studies, or a clinician’s firsthand knowledge of patients and anecdotal data. The ultimate goal of translational research is to move a concept or observation forward into clinical application. However, members of the partnership 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 basic and clinical science.

This mechanism is intended to fund a broad range of translational studies, including, but not limited to, the following:

• Studies advancing/translating in vitro and/or animal studies to applications with human samples/cohorts.
• Late-stage preclinical work leading to/preparing for a clinical trial, e.g., Investigational New Drug (IND) application submission.
• Pilot, proof-of-principle clinical trials (must include documentation of an existing IND or Investigational Device Exemption (IDE), if applicable).
• Correlative studies that are associated with an open/ongoing or completed clinical trial and projects that develop endpoints for clinical trials.

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.

Preliminary data to support the feasibility of the research hypotheses and research approaches are required; however, these data do not necessarily need to be derived from studies of lung cancer. Clinical trials are supported by this award mechanism and, if proposed, require the submission of Attachment 8, Human Subject Recruitment and Safety Procedures.

Military Relevance: The LCRP seeks to support research that is relevant to the healthcare needs of military Service members, Veterans, and their families. Military relevance will be considered in determining relevance to the mission of the DHP and FY18 LCRP during programmatic review. Investigators are strongly encouraged to consider the following characteristics as examples of how a project may demonstrate military relevance:

• Use of military or VA patient populations, biospecimens, data/databases, or programs in the proposed research.
• Collaboration with DoD or VA investigators.
• Involvement of military consultants (Army, Air Force) or specialty leaders (Navy, Marine Corps) to the Surgeons General in a relevant specialty area.
• Description of how the knowledge, information, products, or technologies gained from the proposed research could be implemented in a dual-use capacity to address a military need that also benefits the civilian population.
• Explanation of how the project addresses an aspect of lung cancer that has direct relevance to military Service members, Veterans, or other Military Health System beneficiaries, including environmental exposures other than tobacco.

The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public.

The anticipated direct costs budgeted for the entire period of performance for an FY18 LCRP Translational Research Partnership Award will not exceed $900,000. Refer to Section II.D.5,Funding Restrictions, for detailed funding information.