OpportunityTitle: DoD FY11 Prostate Cancer Research Program Clinical Trial Award
Description: The PCRP Clinical Trial Award mechanism was first offered in FY01. Since then, 97 Clinical Trial Award applications have been received, and 18 have been recommended for funding. The PCRP Clinical Trial Award supports rapid execution of clinical trials (Phase 0/I, Phase I, Phase I/II, or Phase II for drugs, Class II or III for devices) to test novel approaches with the potential to have a major impact on the treatment or management of prostate cancer. Funding from this award mechanism must support a clinical trial and cannot be used for preclinical research studies. A clinical trial is defined as a prospective accrual of patients where an intervention (i.e., drug, device, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the subject of that intervention or interaction. Exploratory clinical trials (Phase 0) may be submitted for the PCRP Clinical Trial Award, but they must be accompanied by a Phase I clinical trial (Phase 0/I). Principal Investigators (PIs) must clearly specify in their applications which type of clinical trial, including phase or class designation (if applicable), is being proposed. PIs are encouraged to accompany their trials with correlative studies that address one or more of the PCRP focus areas (see Program Description above). PIs conducting correlative studies must describe in detail the study aims, procedures or methods, and plans for data management and analysis, including an appropriately powered statistical plan. For more information on clinical trials and phase/class of study, a Human Subject Resource Document is provided at https://cdmrp.org/Program_Announcements_and_Forms/. Studies in a broad range of areas related to prostate cancer clinical management and care will be accepted under this PCRP Clinical Trial Award, including but not limited to: &#239;&#191;&#189; Evaluations of novel drugs, biologics, or devices &#239;&#191;&#189; Survivorship &#239;&#191;&#189; Diet &#239;&#191;&#189; Quality of life &#239;&#191;&#189; Psychosocial interventions &#239;&#191;&#189; Behavioral studies All applications for the Clinical Trial Award are highly recommended to address one of the FY11 PCRP overarching challenges. The PCRP seeks to fund projects from the wide spectrum of basic to clinical research; however, if the proposed project does not address one of the overarching challenges, the application should provide a description to justify how the project will nevertheless address a critical need in the field of prostate cancer research and/or patient care. The following are important aspects of submission for the PCRP Clinical Trial Award: &#239;&#191;&#189; The application should include a thorough discussion of the potential for the proposed intervention and study results to lead to a major impact on the treatment or management of prostate cancer. &#239;&#191;&#189; New for FY11: The application must include documentation of an existing Investigational New Drug (IND) or Investigational Device Exemption (IDE), if applicable. &#239;&#191;&#189; The intervention to be tested should be based on sound scientific rationale that is established through logical reasoning, critical review, and analysis of the literature. &#239;&#191;&#189; The inclusion of preliminary data that are relevant to the proposed research is required; any unpublished preliminary data should originate from the laboratory of the PI or collaborators named on this application. &#239;&#191;&#189; The application should demonstrate availability of and access to a suitable human subject population that will support a meaningful outcome for the study. The PI should discuss how accrual goals will be achieved, and how standards of care may impact the study population. &#239;&#191;&#189; The application should demonstrate documented availability of and access to the drug/compound, device, and/or materials needed. &#239;&#191;&#189; The proposed clinical trial should include clearly defined and appropriate endpoints. &#239;&#191;&#189; 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. &#239;&#191;&#189; The proposed clinical trial is expected to begin no later than 12 months after the award date. &#239;&#191;&#189; New for FY11: PIs must discuss how the clinical trial will be funded to its planned completion with either: support with funds from the PCRP, support from the applicant institution, and/or support from another agency or entity. Documentation of necessary funding from other sources, if applicable, is required, and will be requested at a later date for Clinical Trial Award applications recommended for funding. &#239;&#191;&#189; New for FY11: The application should include a Transition Plan that describes a clear path to further develop the intervention after the end of the award period of performance. Use of Human Subjects and Human Anatomical Substances: All Department of Defense (DOD)-funded research involving new and ongoing research with human subjects and human anatomical substances must be reviewed by the local Institutional Review Board (IRB) of record. However, IRB approval at the time of submission is NOT required. In addition, these studies must also be reviewed and approved by the US Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), Human Research Protection Office (HRPO). The HRPO is mandated to comply with specific laws and directives governing all research involving human subjects that is supported by the DOD. These laws and directives are rigorous and detailed, and will require information in addition to that supplied to the IRB of record. Allow a minimum of 4 months for regulatory review and approval processes. Refer to the General Application Instructions, Appendix 5, for more information.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: 301-682-5507