DoD Prostate Cancer, Translational Science Award

Organization
DOD
Type
DOD
Application or LOI Due Date
07-29-2021
Number
W81XWH-21-PCRP-TSA
Brief Description

The FY21 PCRP Translational Science Award (TSA) mechanism supports advanced translational research that will foster transformation of promising ideas in prostate cancer into clinical applications, ultimately providing a solution to one or more of the FY21 PCRP Overarching Challenges. Translational research may be defined as an integration of basic science and clinical observations. Observations that drive a research idea may originate from a laboratory discovery, population-based studies, or a clinician’s firsthand knowledge of patient care. Principal Investigators (PIs) should not view translational research as a one-way continuum from bench to bedside, but can include a reciprocal flow of ideas and information between basic science and clinical science (bench to bedside and/or bedside to bench). This mechanism is intended to fund a broad range of translational studies including, but not limited to, the following:

• Advanced preclinical studies aimed at translating results from animal studies to applications with human samples/cohorts. The TSA is not intended to support initial mechanistic studies of a new target.

• Late-stage preclinical work leading to/preparing for a clinical trial, e.g., an Investigational New Drug (IND) application submission

• Correlative studies that are associated with an open/ongoing or completed clinical trial, e.g., projects that utilize biospecimens from clinical trials to improve clinical management of prostate cancer and/or define new areas of research

• Projects that develop endpoints for clinical trials

Preliminary data to support the scientific rationale and feasibility of the research approaches are required. The inclusion of additional preliminary data to support the clinical relevance of the idea is strongly encouraged.

Applications should carefully consider study sample size to ensure that the study results will be able to support valid conclusions and further translation towards clinical application. It is the applicant’s responsibility to demonstrate access to the required resources or populations necessary for the study and to provide sufficient evidence that the sample size is appropriate to meet the objectives of the study. Additional guidance regarding statistical rigor for preclinical studies is provided at the end of this section.

As the ultimate goal of translational research is to move a concept or observation forward into clinical application, applications must include a detailed transition plan that articulates the pathway to moving the project’s findings to the next phase of development after successful completion of the award and how the PI(s) will continue advancing the research toward making a clinical impact, even if clinical impact is not an immediate outcome.

Research involving human subjects is permitted under this funding opportunity; however,

clinical trials are not allowed. Correlative studies associated with an existing clinical trial are particularly encouraged, provided they are determined to be no greater than minimal risk by the Institutional Review Board (IRB) of record and the U.S. Army Medical Research and Development Command (USAMRDC), Office of Research Protections (ORP), Human Research Protection Office (HRPO).

Partnering PI Option: The FY21 PCRP TSA encourages applications that include meaningful and productive collaborations between investigators. The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application; collaborations between basic science and clinical researchers are highly encouraged. The Partnering PI Option is structured to accommodate two 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 will be identified as a Partnering PI. Both 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.

The types of awards made under the program announcement will be assistance agreements. An assistance agreement is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. The level of involvement on the part of the Department of Defense (DOD) during project performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement. Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award. The award type, along with the start date, will be determined during the negotiation process.

A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, the CDMRP encourages applicants to review the recommendations (https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY21 PCRP priorities.

The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public. Collaborations between researchers at military or Veteran institutions and non-military institutions are strongly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the partners bring to the research effort, ultimately advancing cancer research that is of significance to the Warfighter, military families, and the American public.

The anticipated direct costs budgeted for the entire period of performance for an FY21 PCRP Translational Science Award will not exceed $750,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Awards will be made no later than September 30, 2022. For additional information refer to Section II.F.1, Federal Award Notices. The CDMRP expects to allot approximately $7.2M to fund approximately six FY21 PCRP Translational Science Award applications. Funding of applications received is contingent upon the availability of federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY21 funding opportunity will be funded with FY21 funds, which will expire for use on September 30, 2027.

Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All DOD-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRDC ORP HRPO prior to research implementation. This administrative review requirement is in addition to the local IRB or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. Refer to the General Application Instructions, Appendix 1, and the Human Research Protections Office Resources and Overview document available on the electronic Biomedical Research Application Portal (eBRAP) “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information.

If the proposed research is cooperative (i.e., involving more than one institution), a written plan for single IRB review arrangements must be provided at the time of application submission or award negotiation. The lead institution responsible for developing the master protocol and master consent form should be identified and should be the single point of contact for regulatory submissions and requirements.

Clinical research is defined as: (1) patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) epidemiologic and behavioral studies; and (3) outcomes research and health services research. Note: Studies that meet the requirements for IRB Exemption 4 are not considered CDMRP-defined clinical research. IRB Exemption 4 refers to research involving the collection or study of existing de-identified specimens or data, if these sources are publicly available.

Clinical trials are not allowed. 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 the interventions on biomedical or behavioral health-related outcomes.

Use of DOD or Department of Veterans Affairs (VA) Resources: If the proposed research involves access to active-duty military patient populations and/or DOD or VA resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Refer to

Section II.D.2.b.ii, Full Application Submission Components, for detailed information. Refer to the General Application Instructions, Appendix 1, for additional information.

Research Involving Animals: All DOD-funded research involving new and ongoing research with animals must be reviewed and approved by the USAMRDC ORP Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use Committee (IACUC) of record. IACUC approval at the time of submission is not required. Allow at least 3 to 4 months for ACURO regulatory review and approval processes for animal studies. Refer to the General Application Instructions, Appendix 1, for additional information.

All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. The standards are described in Landis SC, et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature, 490:187-191 (www.nature.com/nature/journal/ v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies. Applicants should consult the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The ARRIVE guidelines can be found at http://www.elsevier.com/__data/promis_misc/622936arrive_ guidelines.pdf.