OpportunityTitle: DoD Prostate Cancer, Clinical Trial Award
Description: The intent of the PCRP Clinical Trial Award (CTA) is to accelerate the development of new interventions to decrease the burden of prostate cancer by supporting the rapid implementation of early-phase clinical trials (e.g., Phase 0, Phase I, pilot Phase II). Therapeutic approaches proposed for testing through the CTA may include novel interventions or the testing of existing interventions for new indications in prostate cancer, but must represent hypothesis-based approaches for the treatment of prostate cancer that will have a major impact on one or more of the FY19 PCRP Overarching Challenges. Interventions may include drugs, devices, biologics, targeted radionuclides, surgical procedures, behavior modifications, or other types of interventions based on investigator discretion. It is anticipated that outcomes from studies funded by this award will provide scientific rationale for subsequent development of larger, efficacy-based clinical trials of interventions that will transform prostate cancer patient care. Funding from this award mechanism must support a clinical trial and may not be used for preclinical research studies. Projects funded by the CTA are expected to facilitate the rapid implementation of early-phase clinical trials (e.g., Phase 0, Phase I, pilot Phase II). New FY19 definition: A clinical trial is 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. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. Examples of acceptable studies include, but are not limited to, the following: &#8226; Studies designed to identify an appropriate population or subpopulation for future clinical trials. &#8226; Identification of the dosage, duration, and/or delivery strategy of an intervention. &#8226; Evaluation of the feasibility of the intervention in prostate cancer. &#8226; Evaluation of efficacy and safety of the intervention. If the proposed clinical trial involves the use of a drug that has not been approved by the U.S. Food and Drug Administration (FDA) for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) may be required. It is the responsibility of the applicant to provide evidence from the Institutional Review Board (IRB) of record or the FDA if an IND is not required. If an IND is required, the IND application must be approved by the FDA by the Clinical Trial Award application submission deadline. The IND should be specific for the product (i.e., the product should not represent a derivative or alternate version of the investigational agent described in the IND application) and indication to be tested in the proposed clinical trial. For more information on IND applications, the FDA has provided guidance at https://www.fda.gov/drugs/developmentapprovalprocess/ howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm. If the investigational product is a device, then an Investigational Device Exemption (IDE) application to the FDA that meets all requirements under 21 CFR 812 may be required. It is the responsibility of the applicant to provide evidence from the IRB of record, or from the FDA if an IDE is not required or if the device qualifies for an abbreviated IDE. If an IDE is required, the IDE application must be approved by the FDA by the Clinical Trial Award application submission deadline. The IDE should be specific for the device (i.e., should not represent a derivative or modified version of the device described in the IDE application) and indication to be tested in the proposed clinical trial. Refer to Attachment 10, Regulatory Strategy, for additional details on documentation of FDA applications. The Government reserves the right to withdraw funding if an IND or IDE application is necessary but is not in place prior to the application submission deadline. Recruitment Milestones: The application must indicate the quarterly enrollment targets across all sites in Attachment 5: Statement of Work (SOW). Successful applicants will work with USAMRAA to establish milestones for human subject recruitment. Continued support for the project will be based upon satisfactory progress in meeting the established milestones. The following are important aspects of the PCRP Clinical Trial Award: &#8226; The proposed clinical trial is expected to begin no later than 12 months after the award date. &#8226; The proposed intervention(s) to be tested should offer significant potential impact on the lives and health of individuals with prostate cancer within the context of the FY19 PCRP Overarching Challenges, and should improve patients&#8217; outcomes (longevity, quality of life, etc.) relative to existing treatments and/or standard of care. &#8226; Inclusion of preliminary data relevant to the proposed clinical trial is required. &#8226; The proposed clinical trial must be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature. &#8226; The application should describe the planned indication for the product label, if appropriate, and include an outline of the product development plan required to support that indication. &#8226; The application should demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the study. The Principal Investigator (PI) should discuss how accrual goals will be achieved and how standards of care may impact the study population. &#8226; The application should demonstrate documented availability of and access to the drug/ compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study. The quality and stability of the product should be documented and commensurate with current FDA manufacturing standards applicable to the type and phase of product being developed (i.e., Quality System Regulation, Good Manufacturing Practice [GMP] guidelines). Funds from this award may not be used to support costs associated with producing or obtaining the specified intervention from the manufacturer. &#8226; The application should reflect the study team&#8217;s experience interacting with the FDA, including previous FDA submissions, if applicable. &#8226; The proposed clinical trial design should include clearly defined objectives and appropriate endpoints/outcome measures, and comply with current Good Clinical Practice (GCP) guidelines. &#8226; The application should include a clearly articulated statistical analysis plan, appropriate statistical expertise on the research team, and a power analysis reflecting sample size projections that will answer the objectives of the study. &#8226; The application should include a clearly articulated data management plan and use of an appropriate database to safeguard and maintain the integrity of the data. If FDA-regulated, the trial must use a 21 CFR 11-compliant database and appropriate data standards. For more on data standards, see https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ FormsSubmissionRequirements/ElectronicSubmissions/UCM511237.pdf. &#8226; The application should include a clearly articulated safety management plan outlining how safety pharmacovigilance will be conducted, as applicable. &#8226; The application should include a clearly articulated clinical monitoring plan outlining how the study will be monitored for GCP compliance. &#8226; The application should describe which member(s) of the research team will guide the clinical protocol through the local IRB of record and other Federal agency regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. &#8226; The application should include a Transition Plan (including potential funding and resources) showing how the product will progress to the next clinical trial phase and/or delivery to the market after the successful completion of the FY19 PCRP Clinical Trial Award. &#8226; The application should clearly demonstrate strong institutional support and, if applicable, a commitment to serve as the FDA regulatory sponsor, ensuring all sponsor responsibilities described in 21 CFR 312, Subpart D, are fulfilled. &#8226; Funded trials are required to post a copy of the informed consent form used to enroll subjects on a publicly available Federal website in accordance with Federal requirements described in 32 CFR 219. &#8226; Funded studies are required to register the study in the National Institutes of Health (NIH) clinical trials registry, www.clinicaltrials.gov, prior to initiation of the study. Refer to the General Application Instructions, Appendix 1, Section C, for further details. 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, 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 FY19 PCRP priorities. 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 FY19 PCRP CTA will not exceed $2,000,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. The CDMRP expects to allot approximately $12.8M to fund approximately four Clinical Trial 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 FY19 funding opportunity will be funded with FY19 funds, which will expire for use on September 30, 2025. Awards will be made no later than September 30, 2020. For additional information, refer to Section II.F.1, Federal Award Notices. The type of awards made under the Program Announcement will be assistance agreements (grants or cooperative agreements). 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. An assistance agreement (grant or cooperative agreement) is appropriate when the Federal Government transfers a &#8220;thing of value&#8221; to a &#8220;state, local government,&#8221; or &#8220;other recipient&#8221; 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 &#8220;no substantial involvement&#8221; 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. 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 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. Additional time for regulatory reviews may be needed for clinical studies taking place in international settings. 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 as a stand-alone study. Submission to HRPO of protocols involving more than the scope of work in the DoD-funded award will require HRPO review of the entire protocol (DoD and non-DoD funded). DoD human subjects protection requirements may be applied to non-DoD funded work and necessitate extensive revisions to the protocol. Applications that involve recruitment of human subjects must indicate the quarterly enrollment targets across all sites in Attachment 5: Statement of Work (SOW). Successful applicants will work with USAMRAA to establish milestones for human subjects recruitment. Continued support for the project will be based upon satisfactory progress in meeting the established milestones. Refer to the General Application Instructions, Appendix 1, Section B, and the Human Subject Resource Document available on the electronic Biomedical Research Application Portal (eBRAP) &#8220;Funding Opportunities &amp; Forms&#8221; web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information. If the IRB determines that a trial presents greater than minimal risk to human subjects, the DoD requires an independent research monitor with expertise consistent with the nature of risk(s) identified within the research protocol. If applicable, refer to the General Application Instructions, Appendix 1, Section B (Research Monitor Requirement) for more information on study reporting authorities and responsibilities of the research monitor. Multi-Institutional Clinical Trials: If the proposed clinical trial is multi-institutional, plans for the multi-institutional structure governing the research protocol(s) should be outlined in Attachment 11: Study Personnel and Organization. The lead organization 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. A single IRB/EC pathway is strongly recommended whenever possible. The master protocol and consent form must be reviewed by the HRPO prior to distribution to the additional sites for IRB/EC review. Communication and data transfer among the collaborating institutions, as well as how specimens and/or imaging products obtained during the study will be handled, should be included in the appropriate sections of the application. A separate intellectual and material property plan agreed upon by all participating institutions is also required for multi-institutional clinical trials. PIs are encouraged to integrate and/or align their research projects with DoD and/or Department of Veterans Affairs (VA) research laboratories and programs. Collaboration with the DoD or VA is also encouraged.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: CDMRP Help Desk &lt;br/&gt;Phone:  301-682-5507 &lt;br/&gt;Email:  help@eBRAP.org