The Dana-Farber/Harvard SPORE in Breast Cancer will make a substantial investment in developmental projects. We have allocated $160,000 per year to Developmental Projects, representing 10 percent of our direct costs. In addition, a substantial amount of money will be available for our use through the office of Joseph Martin, Dean of the Harvard Medical School. This fund will specifically support Developing Projects that support the SPORE in Breast Cancer at the Medical School. Projects will be funded in two categories: Clinical Discovery and Basic Discovery. Clinical Discovery Projects are clinical studies directly impacting women with breast cancer or at risk for the disease. Funding for these Projects might support clinical research costs, which are not provided by Core Resources. These costs might include subsidized tests, special data-management services, or questionnaire development. Additionally, Clinical Discovery funding may be used for correlative laboratory research, where this research supports a companion clinical study involving human subjects (exemplified in Developing Project 1, below). However, all Projects in this category must involve living subjects, whose lives have been touched by breast cancer (affected with breast cancer, at-risk for breast cancer, or the relatives of women with breast cancer). Basic Discovery Projects cover fundamental studies, including laboratory investigation, behavioral science, patterns of care, informatics, and modeling. Basic Discovery Projects are not constrained by required involvement of human subjects; however, they may involve measurements in patient populations or tissues. A certain amount of overlap will exist between funding categories. Basic Discovery Project applicants will be asked to demonstrate eventual relevance of the proposed investigation to human cancer and explain a strategy for translation to clinical studies or practice. In general, Developmental Projects are intended to be hypothesis driven. However, critical technologies may be supported. Monies to support technology may be requested directly in open competition, or the Executive Committee may issue directed RFA?s to fulfill programmatic needs. For instance, the EC may determine the SPORE requires analysis of a sample cohort by gene array. In this case, it may request """"""""bids"""""""" from local providers to provide technical services. Likewise, the Executive Committee will determine the exact mix of Projects and their level of funding. We are requesting funding for an identical number of Projects in each category and have specified funding targets. These targets may change, according to the needs of the SPORE. Each year, we will have at least $160,000 to spend in this highly flexible manner. Despite this flexibility, the more traditional mechanism of open competitions, peer review and awards by a combination of relevance and merit will be typical. The record of achievement of the Developing Projects venture will be scrutinized by both our Internal and External Advisory Boards, by NCI scrutiny during annual non-competitive renewal, and ultimately at the time of competitive renewal. In most cases, awards will go to faculty-level investigators and will support research for a period of one to two years. Second-year awards will require progress reports and will compete with new proposals. Projects will be solicited from the entire membership of the DF/HCC; however, special waivers may be granted to local applicants from outside the Cancer Center. The grant will cover direct costs only and will not """"""""double-pay"""""""" indirect costs to receiving institutions. The Administration, Evaluation and Planning Core will handle indirect cost arrangements with recipient institutions. This process is transparent to investigators and is used to award developmental funds from the DF/HCC. Awards may be made to Clinical or Postdoctoral Fellows, whose accomplishments are outstanding. In general, awards are preferentially given to faculty with Principal Investigator status.
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