DoD Ovarian Cancer Clinical Development Award

Description

The OCRP Clinical Development Award is intended to provide support for the translation of promising preclinical findings into products for clinical applications, including prevention, detection, diagnosis, treatment, or quality of life.The goal of this award mechanism is to accelerate the clinical introduction of medical products and technologies that target ovarian cancer biology. Near-term clinical impact is expected. Proof of concept demonstrating the potential utility of the proposed product or a prototype/preliminary version of the proposed product should already be established; thus, preclinical studies in animals are not allowed. Small-scale clinical trials (Phase 0, Phase 1), studies enriching a clinical trial, and projects related to or associated with ongoing or completed clinical trials are allowed. Relevant data, either published or unpublished, that support the study rationale are required. Important aspects of the application to the FY18 OCRP Clinical Development Award:• The application should demonstrate availability of, and accessibility to, a suitable human subject population or anatomical samples that will support a meaningful outcome for the study. Include a discussion of feasibility of the proposed study and how accrual goals will be achieved.• The application should demonstrate documented availability of, and accessibility to, the drug/compound, device, and/or materials needed. • The proposed study should include clearly defined and appropriate endpoints. • The application should include a detailed statistical analysis plan, including a power analysis reflecting sample size projections that will clearly answer the objectives of the study. • Applications must also include a transition plan (including potential funding and resources) showing how the result will progress to the next level of development (e.g., future clinical trials, delivery to the military or civilian market) after the completion of the OCRP award. Optional Nested Early-Career Investigator: For Principal Investigators (PIs) that are proposing clinical trials, this FY18 Clinical Development Award mechanism is offering an optional nested Early-Career Investigator to foster the next generation of ovarian cancer investigators in the conduct of clinical trials. One Early-Career Investigator can be named within a given application, and the Early-Career Investigator must be within 5 years of their last postdoctoral research position (Ph.D.) or clinical fellowship (M.D.), or equivalent at the full application submission deadline. The Early-Career Investigator must meet specific eligibility criteria as described in Section I.C, Eligibility Information. Applications that contain a nested Early-Career Investigator will qualify for a higher level of funding as described under Section II.D.5, Funding Restrictions. The PI on the Clinical Development Award must mentor the nested Early-Career Investigator.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, S.C., et al., A call for transparent reporting to optimize the predictive value of preclinical research, Nature 2012, 490:187-191.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 OCRP Clinical Development Award will not exceed $600,000, and the anticipated direct costs budgeted for the entire period of performance for an FY18 OCRP Clinical Development Award with an optional Early-Career Investigator will not exceed $800,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. 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 U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), Human Research Protection Office (HRPO), prior to research implementation. This administrative review requirement is in addition to the local Institutional Review Board (IRB) or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. The HRPO is mandated to comply with specific laws and requirements governing all research involving human anatomical substances, human subjects, or human cadavers that is supported by the DoD. These laws and requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. When possible, protocols should be written for research with human subjects and/or human anatomical substances that are specific to the DoD-supported effort outlined in the submitted application. Submission to HRPO of protocols covering more than the scope of work in the DoD-funded award will require HRPO review of the entire protocol as DoD-supported research and may include extensive modifications to meet DoD human subjects protection requirements. The types of awards made under the Program Announcement will be assistance agreements (grants or cooperative agreements). The level of involvement on the part of the DoD during project performance is the key factor in determining whether to award a grant or cooperative agreement. Extramural Organizations: An assistance agreement (grant or cooperative 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. 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 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.The CDMRP intends that information, data, and research resources generated under awards funded by this Program Announcement be made available to the research community (which includes both scientific and consumer advocacy communities) and to the public at large. For additional guidance, refer to the General Application Instructions, Appendix 2, Section K.Awards will be made no later than September 30, 2019. For additional information refer to Section II.F.1, Federal Award Notices.

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