OpportunityTitle: DoD Lung Cancer Research Program Clinical Exploration Award
Description: The Clinical Exploration Award (CEA) mechanism supports rapid execution of early-phase, proof-of-principle clinical trials to examine hypothesis-based, innovative interventions that have the potential to resolve current clinical barriers and result in a profound impact on the clinical management of lung cancer. While therapeutic approaches proposed for testing through the CEA must represent novel, hypothesis-based, &#8220;outside-the-box&#8221; approaches for treating lung cancer, they may include therapies already in clinical use, or undergoing clinical testing for other diseases, provided that the proposed use for lung cancer would lead to a major advancement for treating the disease. Outcomes from studies funded by this award are anticipated to provide scientific rationale for subsequent development of larger, efficacy-based clinical trials of interventions that will transform lung cancer clinical care. Submissions from and partnerships with investigators at military treatment facilities, military labs, and Department of Veterans Affairs (VA) medical centers and research laboratories are strongly encouraged. Clinical Trials: The CEA supports clinical trials encompassing Phase 0, Phase I, or pilot Phase II for drug or drug combinations, Class II or III devices, or other types of trials that conduct early clinical testing of innovative approaches for lung cancer. Information on clinical trials and phases/classes of study is provided in the &#8220;Human Subject Resource Document&#8221; available for download from eBRAP at https://ebrap.org/eBRAP/public/Program.htm. Projects that only propose correlative studies from ongoing or completed clinical trials are not allowed. Investigators wishing to apply for funding for correlative studies should consider submitting an application to the FY16 LCRP Investigator-Initiated Translational Research Award mechanism (Funding Opportunity Number: W81XWH-16-LCRP-IITRA). Because the CEA seeks to support highly innovative, high-impact early-phase clinical trials with near-term clinical relevance, it is the responsibility of the PI to clearly articulate how the proposed study represents research that is beyond conventional therapeutic approaches for lung cancer. Studies in a broad range of areas related to lung cancer clinical management will be considered under the CEA, including but not limited to, evaluation of drugs, biologics, devices, surgical procedures, behavior modifications, or other types of therapeutic approaches. Key elements of this award are as follows: &#8226; The application should clearly specify the type of clinical study, including phase or class designation (if applicable), that is being proposed. &#8226; The application must include documentation of an existing Investigational New Drug (IND) or Investigational Device Exemption (IDE), if applicable. &#8226; The proposed intervention must be based on sound scientific rationale that is established through logical reasoning, critical review and analysis of the literature, and preliminary data. &#8226; The application should demonstrate availability and accessibility of a suitable human subject population that will support a meaningful outcome for the study. &#8226; The application must demonstrate documented availability and accessibility of the drug/compound, device, and/or other materials needed, e.g., a letter from the manufacturer assuring an adequate supply of the agent (and placebo, if necessary). &#8226; The proposed study should include clearly defined and appropriate endpoints. &#8226; 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. &#8226; The proposed study is expected to begin no later than 12 months after the award date. &#8226; The application should include a Transition Plan that describes a clear path for further clinical development. &#8226; Relevance to Military Beneficiaries: The application should clearly articulate how the proposed research is relevant to military Service members, Veterans, and their families.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: CDMRP Help Desk &lt;br/&gt;Phone:      301-682-5507 &lt;br/&gt;Email:       help@eBRAP.org