DoD Translational Team Science Award for Cancer Clinical Research

New for FY17: The FY17 PRCRP TTSA encourages studies investigating:

• Patient-reported outcomes, survivorship, and/or quality of life
• Precursor lesions of metastatic disease
• Differences in prognosis and response to treatment with respect to primary nodal status
• The relationship between prevention and longitudinal cancer risk outcomes
• Tumor heterogeneity (e.g., genetic, epigenetic, immunological) and its association to the tumor microenvironment

The TTSA may support studies in animal models, human subjects, and human anatomical substances. Accordingly, development or use of relevant preclinical models may be included. The TTSA is not intended to support high-throughput screenings, sequencing, etc.

Important aspects of the TTSA mechanism are as follows:

• Collaboration: The success of the project depends on the unique skills and contributions of each collaborator. At least two, and up to three, Principal Investigators (PIs) must partner in one overarching study in at least one of the required FY17 PRCRP Topic Areas in Section II.A.1. At least one military or VA investigator is encouraged to be included as an equal partner in the research offering both intellectual investment and research effort.
○ A military or VA investigator is defined as an investigator who is active duty, active reserve, active duty detailed to agencies outside of the DoD, etc., or an investigator at a VA research facility. The military/VA investigator should have a substantial role in the research and should not be included only for access to active duty military and/or VA populations (see “Military Relevance” below).
• Translation: The application should provide evidence for the reciprocal transfer of information between basic and clinical science or vice versa in developing and implementing the research plan. Translational research should include correlative studies based on completed or ongoing clinical trials, annotated biorepositories, or translational research. The application should demonstrate how the study will leverage clinical information to address knowledge gaps in resulting outcomes, validate key research findings, and expand upon potentially transformative results, or investigate novel findings.
• Military Relevance: The proposed research must address at least one of the FY17 PRCRP Military Relevance Focus Areas in Section II.A.2. The proposed research must be relevant to active duty Service members, Veterans, and other military beneficiaries. Military relevance highlights the need to address exposures, conditions, or circumstances that are unique to the military or disproportionately represented within the military beneficiary population. Studies into cancer knowledge gaps that may affect an individual’s mission readiness, patient care, and treatment options are critical. Military relevance should be articulated with respect to the overall Military Health System, the VA, and the mission of the DHP. For more information, review the following websites: Military Health System (http://www.health.mil), VA (http://www.va.gov/), the PRCRP (http://cdmrp.army.mil/prcrp/default), and the PRCRP Report to Congress (http://cdmrp.army.mil/prcrp/reports/reports).
• Impact: The proposed research should have the potential to have a significant impact on cancer research and/or patient care, and have the potential to accelerate the movement of promising ideas (in prevention, diagnosis, detection, prognosis, treatment, and/or survivorship) into clinical applications for at least one of the FY17 PRCRP Topic Areas in Section II.A.1.
• Preliminary Data Required: Clinical data must be included in the application and/or citations of the investigators’ work that are relevant to the proposed studies.

The anticipated direct costs budgeted for the entire period of performance for an FY17 PRCRP TTSA will not exceed $1,000,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Collaborations with a Military/VA investigator are encouraged. All PIs are encouraged to align their research projects with DoD and/or VA research laboratories and programs. While not a complete list, the following websites may be useful in identifying additional information about ongoing DoD and VA areas of research interest or potential opportunities for collaboration:

Air Force Research Laboratory
http://www.wpafb.af.mil/afrl
Armed Forces Radiobiology Research Institute
http://www.usuhs.edu/afrri/
Defense Advanced Research Projects Agency
http://www.darpa.mil/
Defense Technical Information Center
http://www.dtic.mil
Military Infectious Disease Research Program
https://midrp.amedd.army.mil
Military Operational Medicine Research Program
https://momrp.amedd.army.mil
Naval Health Research Center
http://www.med.navy.mil/sites/nhrc
Navy and Marine Corps Public Health Center
http://www.nmcphc.med.navy.mil/
Office of Naval Research
http://www.med.navy.mil/
Office of the Under Secretary of Defense for Acquisition, Technology and Logistics
http://www.acq.osd.mil
Uniformed Services University of the Health Sciences
https://www.usuhs.edu/research
U.S. Army Medical Research Acquisition Activity
https://www.usamraa.army.mil/
U.S. Army Medical Research and Materiel Command
https://mrmc.amedd.army.mil
U.S. Army Research Laboratory
http://www.arl.army.mil
U.S. Department of Veterans Affairs, Office of Research and Development
http://www.va.gov/oro/
U.S. Naval Research Laboratory
http://www.nrl.navy.mil
Walter Reed Army Institute of Research
http://www.wrair.army.mil/

Cancer clinical research resources: PIs are encouraged to review clinical research and/or trial information and resources available through the National Cancer Institute, Cancer Therapy Evaluation Program (CTEP). Detailed information on the activities of the CTEP can be found through the following links:

• NCI’s National Clinical Trials Network (NCTN): http://www.cancer.gov/research/areas/clinical-trials/nctn
• Experimental Therapeutics Clinical Trials Network (ETCTN): https://ctep.cancer.gov/initiativesPrograms/etctn.htm
• Adult Brain Tumor Consortium (ABTC) https://ctep.cancer.gov/MajorInitiatives/Adult_Brain_Tumor_Consortium.htm
• Blood and Marrow Clinical Trials Network (BMT CTN): https://ctep.cancer.gov/branches/cgcb/blood_and_marrow_clinical_trials_network.htm
• Cancer Immunotherapy Trials Network (CITN): https://ctep.cancer.gov/MajorInitiatives/cancer_immunotherapy_trials_network.htm
• Pediatric Brain Tumor Consortium (PBTC): https://ctep.cancer.gov/investigatorResources/childhood_cancer_resources.htm
• Pediatric Preclinical Testing Consortium (PPTC): https://ctep.cancer.gov/MajorInitiatives/Pediatric_Preclinical_Testing_Consortium.htm

The FY17 PRCRP TTSA mechanism requires at least two, and up to three, 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 other PI(s) will be identified as a Partnering PI(s). Initiating and Partnering PIs each have different submission requirements, as described in Section II.D.2, Content and Form of the Application; however, all PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work, and other required components. If recommended for funding, each applicant will receive his or her own award.

Applications should include clearly stated plans for interactions among all PIs and organizations involved. The plans must include communication, coordination of research progress and results, and data transfer. Additionally, 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.