PILOT AND FEASIBILITY PROGRAM ABSTRACT The Pilot and Feasibility program will be a central and cohesive piece of the Pediatric Center of Excellence. The overall goal of the Pilot and Feasibility Program is to develop the science of investigators who need to obtain preliminary data to inform the design of future clinical trials in children with kidney disease. The Pilot and Feasibility Program will work closely with the Administrative Core, the Design/Analysis Core, the Clinical Phenotyping Core, and the Learning Health System Core to publicize, elicit, review, and fund proposals. The Pilot and Feasibility program will promote collaboration with investigators outside The Children's Hospital of Philadelphia and our regional academic partners at Johns Hopkins University. We will fund 2-4 pilot projects during the award period, with each project receiving $50,000 in direct support per year for a maximum of two years. At least one proposal will be funded from outside the research base. Additionally, the Department of Pediatrics at the Children?s Hospital of Philadelphia has generously agreed to fund an extra Pilot study at $50,000 per year for two years. All pilot and feasibility projects will be chosen meritoriously through peer review by a Scientific Advisory Committee. The Pilot and Feasibility Program will offer mentoring, through the formation of sub-committees, for those investigators who need input on their research projects throughout the submission and review process. To achieve the following specific aims and accomplish the overall research goals of the Pediatric Center of Excellence, each Pilot and Feasibility study will make use of the resources provided by at least one of the Center?s three Cores.
The Specific Aims of the Pilot and Feasibility Program are: 1) To stimulate and solicit new project ideas that support the overall research goal of the Pediatric Center of Excellence?namely to decrease the barriers to implementing clinical trials in children with kidney disease; 2) To encourage submission of pilot project proposals by junior investigators and to mentor these investigators in the revision of their proposals, as needed; 3) To review pilot project submissions for their scientific merit, level of innovation, and cohesion with the overall research goals and three Cores of the Pediatric Center of Excellence; and 4) To promote the development of new research directions, acquiring preliminary data that will be the foundation for applications for future independent research support in clinical trials. The Pilot and Feasibility Program will build upon the strong pediatric nephrology research experience at the Children?s Hospital of Philadelphia, the outstanding talent from the broader local scientific community at the University of Pennsylvania, and the regional expertise offered by Johns Hopkins University. We anticipate that the selected pilot projects will provide investigators the opportunity to generate preliminary data that will form the basis for future, competitive funding proposals in clinical trials designed to prevent, treat, or slow the progression of kidney disease in children, to identify novel targets for future therapies, and to better understanding the mechanisms of kidney disease. 1
