DoD Peer Reviewed Cancer, Translational Team Science Award

The FY23 PRCRP TTSA supports hypothesis-driven translational studies. These studies must be associated with ongoing or completed clinical trial. The proposed project should focus on research for the next-phase clinical trial or future clinical application. The TTSA is intended to support advanced translational studies that are based on results from clinical investigations and to utilize information from the clinical trials for research that would then inform the clinic.

While funding for clinical trials is allowed, the TTSA is intended to support multi-investigator, multidisciplinary teams to perform clinical research studies and not only to fund a clinical trial. Research projects funded by the TTSA should address critical knowledge gaps in clinical outcomes, validate key research results, expand upon potentially game-changing results, or investigate novel clinical findings. The TTSA is not intended to support high-throughput screenings or sequencing.

The goal of the TTSA is to bring together a synergistic team of investigators to address clinical problems that may have an impact on patient outcomes.

Important aspects of the TTSA mechanism are as follows:

· Collaboration: The TTSA offers a unique opportunity for multiple investigators to partner on one research project. 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 FY23 PRCRP Topic Areas. At least one military or VA investigator is strongly 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 or active- reserve and detailed to agencies outside of the DOD, civilian DOD investigators, 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.

· Translation: The application should provide evidence for the reciprocal transfer of information between laboratory bench science and clinical science or vice-versa in developing and implementing the research plan. Translational research should be based on clinical trials. 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 translational results, or investigate novel findings.

· Preliminary Data Required: Clinical data that are relevant to the proposed studies must be included in the application.

· Data Evaluation: The proposed research should be rigorously designed to include a statistical plan and data analysis plan. The TTSA is intended to have near-term relevance to patients; therefore, the statistical plan and data analysis plan should represent how significant the results and/or outcomes may be on patient outcomes.

· Impact: The proposed research should have the potential to have a significant impact on cancer research and/or patient care and the potential to accelerate the movement of promising ideas (in prevention, detection, diagnosis, prognosis, treatment, and/or survivorship) into clinical applications in at least one of the FY23 PRCRP Overarching Challenges in Section II.A.3 .

Collaborations with a military/VA investigator are strongly encouraged.

The TTSA requires more than one PI. 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 will be identified as a Partnering PI. All PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. If recommended for funding, each PI will be named to an individual award within the recipient organization. For individual submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission .