Defense Health Agency Contracting Activity - DHACA

Description

The ARP Clinical Trial Award mechanism was first offered in FY09. Since then, nine Clinical Trial Award applications have been received, and one has been recommended for funding.The ARP Clinical Trial Award supports clinical trials with the potential to have a major impact on the lives of individuals with ASD. Funding from this award mechanism must support a clinical trial. In general, a clinical trial is defined as a prospective accrual of volunteers for a study where an intervention (e.g., device, drug, behavioral, surgical procedure, or other) is tested on human subjects for a measurable outcome. Refer to the General Application Instructions, Appendix 5, for additional information about studies involving human subjects. The proposed clinical trial is expected to begin no later than 12 months after the award date.Clinical Trial Award applications should:• Demonstrate availability of, and access to, a suitable population that will support a meaningful outcome for the study. Discuss how accrual goals will be achieved and how standards of care may impact the study population.• Describe clearly defined, focused endpoints for the proposed clinical trial that correspond to the design and sample size proposed.• Include pharmacokinetic and pharmacodynamic outcomes, if applicable. Clearly articulate the statistical analyses plan. Include a power analysis reflecting sample size projections that will clearly answer the objectives of the study.• Include a study coordinator who will guide the clinical protocol through Institutional Review Board (IRB), Human Subjects Research Review Board (HSRRB), and other regulatory approval processes; coordinate activities from all sites participating in the trial, and coordinate participant accrual.• Demonstrate institutional support.• Discuss the potential impact of the study results for individuals with ASD.If the study is in support of an application to the U.S. Food and Drug Administration, an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) application should be submitted prior to the grant application submission. The Government reserves the right to withdraw funding if an active exemption from marketing approval for the IND or IDE has not been acquired within 6 months of the award date.Preliminary data (may be from outside of the ASD research field), unpublished results from the laboratory of the Principal Investigator (PI), research team, or collaborators named on this application, that is relevant to the proposed research project, is required. Proposals should also be based on a sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature.Use of Human Subjects and Human Biological Substances: All Department of Defense (DOD)-funded research involving human subjects and human biological substances must be reviewed and approved by the United States Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), Human Research Protection Office (HRPO), in addition to local IRBs. NOTE: Local IRB approval at the time of submission is NOT required. The HRPO is mandated to comply with specific laws and directives governing all research involving human subjects that is conducted or supported by the DOD. These laws and directives are rigorous and detailed, and will require information in addition to that supplied to the local review board. Allow a minimum of 6 months for regulatory review and approval processes for studies involving human subjects. Refer to the General Application Instructions, Appendix 5, for regulatory requirements.

Who can apply

• Unrestricted

Contact

PA HELP: 301-619-7079; cdmrp.pa@amedd.army.mil <br/>eReceipt HELP: 301-682-5507; help@cdmrp.org
cdmrp.pa@amedd.army.mil