Defense Health Agency Contracting Activity - DHACA

Description

NOTE: This funding opportunity requires the submission of a pre-proposal (pre-application). Pre-proposal submissions are described in the Program Announcement and are due no later than 5:00 p.m. Eastern time (ET), March 17, 2010. Application submissions are by invitation only, following pre-proposal screening.The PCRP Impact Award mechanism is being offered for the first time in FY10. This award will support research projects specifically focused on making a major impact on one critical issue in prostate cancer: Reducing or eliminating the over-treatment of primary prostate cancer. Projects funded by this award will, if successful, ultimately change the standard of practice for decision-making in the treatment of primary prostate cancer.Studies conducted under the Impact Award may involve the development of surveillance mechanisms, including improvements in current clinical and diagnostic tools to monitor prostate cancer patients. Proposed projects may include basic, translational, or clinical research, including clinical trials, provided the overall project is hypothesis-based and focused on the problem of prostate cancer over-treatment. It is expected that clinical studies would include longitudinal follow-up to differentiate, at the time of diagnosis, between patients whose disease is indolent and those whose disease will progress to the lethal phenotype. It is anticipated that studies supported by the Impact Award will facilitate assessment of the decision-making process for early stage prostate cancer using clinically relevant endpoints such as progression and need for treatment.Research proposed under the Impact Award may include, but is not limited to, the following topic areas that will address the over-treatment of primary prostate cancer:• Active surveillance (e.g., to standardize inclusion/exclusion criteria)• Biomarkers• Genetic Analysis• Improved staging and grading, to include imaging• Optimal measures for decision making pre- and post biopsy• Optimal measures for follow-up and assessment of progression• Cancer care outcomes research (e.g., quality of life, survivorship) and surveillancePrincipal Investigators (PIs) applying for the Impact Award are expected to establish a multi-disciplinary study team that may include a variety of clinical specialists to effectively address the proposed question. A robust statistical plan and statistical expertise should be included in the proposed investigation.Due to this award’s emphasis on impact, applications must include preliminary data to support feasibility of the study. Any preliminary data provided should be from the laboratory of the PI or member(s) of the research team.Research involving human subjects, including clinical trials, is permitted under this Program Announcement/Funding Opportunity. If the proposed study involves clinical research (including clinical trials), it is expected that regulatory approval will be obtained and the research initiated within the first year of the award. Refer to the General Application Instructions, Appendix 5, for additional information about studies involving human subjects, human subjects data, or human anatomical substances.DOD FY10 Prostate Cancer Impact Award 4It is the responsibility of the PI to clearly and explicitly articulate how the project addresses the following important aspects of the Impact Award:Research Question: Research proposed under the Impact Award must specifically address the reduction or elimination of over-treatment of primary prostate cancer. The proposed work must be based on a sound overall research strategy and may be from any discipline or combination of disciplines. If the study proposed is addressed from a population-based perspective, applications should include a clearly defined population and evidence of appropriate access to the population.Impact: The proposed research must have the potential to revolutionize clinical care of prostate cancer such that the over-treatment of primary disease will be significantly reduced or eliminated.

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