DoD Prostate Cancer Clinical Exploration Award
The PCRP Clinical Exploration Award mechanism was first offered in FY12. At that time, 18 applications were received, and 1 was recommended for funding. This award was not offered in FY13. The Clinical Exploration Award supports early-phase, proof-of-principle clinical trials and correlative studies to investigate hypothesis-based, innovative interventions and/or avenues of research that have the potential to resolve current clinical barriers and result in a profound impact on the management of prostate cancer. While therapeutic approaches proposed for testing through the Clinical Exploration Award must represent novel, hypothesis-based, “outside-the-box” approaches for treating prostate cancer, they may include therapies already in clinical use, or undergoing clinical testing, for other diseases, provided that the proposed use for prostate cancer would lead to a major advancement for treating the disease. 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 clinical care. Clinical Trials: The Clinical Exploration Award will support clinical trials encompassing Phase 0, Phase I, or pilot Phase II for drugs or drug combinations, Class II or III for devices, or other types of trials that conduct early clinical testing of innovative approaches for prostate cancer. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, 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 human subject of that intervention or interaction. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other award mechanisms/funding opportunities being offered. The term “human subjects” is used in this Program Announcement/ Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. Correlative Studies: The Clinical Exploration Award will also support innovative, hypothesis-based, correlative studies that derive from ongoing or completed clinical trials supported by other funding sources. These studies, if successful, will have the potential to significantly inform treatment strategies, identify subsets of patients for treatment with specific therapies, provide increased understanding of biological changes resulting from the intervention in prostate cancer, or provide other insight that will significantly enhance clinical management of prostate cancer. Examples of correlative studies appropriate for submission to the Clinical Exploration Award may include, but are not limited to: • Analyses of biomarkers for prognosis and/or prediction or assessment of therapeutic response or progression • Investigations of the mechanism of action or the development of resistance to a drug • Analyses of immune response or factors associated with progression • Characterization of tumor antigens for the development of new or improved therapies Funding from the Clinical Exploration Award must support a clinical trial or correlative study associated with an ongoing or completed clinical trial and cannot be used for preclinical research studies. Because the Clinical Exploration Award seeks to support clinical trials and correlative studies that may deliver groundbreaking ideas, it is the responsibility of the PI to clearly articulate how the proposed study represents research that is beyond conventional therapeutic approaches for prostate cancer. Studies in a broad range of areas related to prostate cancer clinical management will be considered under the Clinical Exploration Award, including but not limited to evaluations of drugs, biologics, devices, surgical procedures, behavior modifications, or other types of therapeutic approaches. In addition, applicants are expected to address at least one of the PCRP focus areas and are highly encouraged to address one of the PCRP overarching challenges. If the proposed project does not address any of the overarching challenges, the applicant should provide a description to justify how the project will nevertheless address a critical need in prostate cancer clinical management. If the 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, evidence that an Investigational New Drug (IND) application that meets all requirements under the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) has been submitted or will be submitted to the FDA within 60 days of award is required. If the investigational product is a device, evidence that an Investigational Device Exemption (IDE) application that meets all requirements under 21 CFR 812 has been submitted or will be submitted to the FDA within 60 days of award, or that the device is exempt from an IDE, is required. The Government reserves the right to withdraw funding if the IND or IDE application has not been submitted to the FDA within 60 days of the Department of Defense (DoD) award date or if the documented status of the IND or IDE has not been obtained within 6 months of the award date. The following are important aspects of submission for the Clinical Exploration Award: • The application should clearly specify the type of clinical trial, including phase or class designation (if applicable), that is being proposed. • The application must include documentation of application for an IND or IDE, if applicable. • The proposed intervention or correlative study must be based on sound scientific rationale that is established through logical reasoning, critical review and analysis of the literature, and preliminary data. The application should include data showing strong statistical support from preclinical studies that substantiate the appropriateness of further clinical testing. • The application should demonstrate availability of, and access to, a suitable patient 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. • The application should demonstrate documented availability of and access to the drug/ compound, device, and/or other materials needed, as appropriate. The quality of the product should be commensurate with FDA manufacturing standards applicable to the type and phase of product being developed (i.e., Quality System Regulation, Good Manufacturing Practices). • The proposed clinical trial design should include clearly defined and appropriate endpoints, and follow Good Clinical Practice (GCP) guidelines. • The application should include a clearly articulated statistical analysis plan, appropriate statistical expertise, and a power analysis reflecting sample size projections that will clearly answer the objectives of the study. • The proposed clinical trial is expected to begin no later than 12 months after the award date. • The application should include a Transition Plan (including potential funding and resources) showing how the product will progress to the next clinical trial phase.
Office: U.S. Army Medical Research Acquisition Activity
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